# FDA device clearances in United Kingdom: 109 since Nov 2024

Updated October 30, 2026.

FDA made 109 device decisions for applicants in United Kingdom from November 15, 2024 to October 30, 2026: 109 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 74 applicants. The newest, K260306 on October 30, 2026, is RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain... from Smith & Nephew Medical, Ltd..

## The full list

FDA device clearances for applicants in United Kingdom: 109 rows for $5.45, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 5 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/country/united-kingdom

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 109
- 510(k) and De Novo: 109
- PMA: 0
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 109, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | K260306 | RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit... | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260306) |
| October 27, 2026 | K261512 | OsteoSight Spine (v1) | Naitive Technologies, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | SAO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261512) |
| October 27, 2026 | K254226 | PulseAPI SmartWatch | PulseAI, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254226) |
| October 26, 2026 | K260671 | RP Check (RP01) | MD Diagnostics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | CAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260671) |
| October 23, 2026 | K263380 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | United Kingdom | Substantially Equivalent | 510(k) special | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263380) |
| October 23, 2026 | K261982 | RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261982) |
| October 21, 2026 | K261252 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | SCV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261252) |
| September 30, 2026 | K261975 | Braun Aura 7 (6041) | CyDen Limited | United Kingdom | Substantially Equivalent | 510(k) special | OHT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261975) |
| September 25, 2026 | K261977 | Braun Aura 9 (6042) | Cyden Limited | United Kingdom | Substantially Equivalent | 510(k) special | OHT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261977) |
| September 17, 2026 | K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261275) |
| September 16, 2026 | K261896 | iOS CamAPS FX | CamDiab | United Kingdom | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261896) |
| September 12, 2026 | K260133 | CADDIE | Odin Medical Limited | United Kingdom | Substantially Equivalent | 510(k) special | QNP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260133) |
| September 11, 2026 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261338) |
| September 4, 2026 | K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260331) |
| September 2, 2026 | K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U)... | Flexicare Medical Limited. | United Kingdom | Substantially Equivalent | 510(k) traditional | EOQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254026) |
| August 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253817) |
| August 20, 2026 | K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | GYD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262515) |
| August 10, 2026 | K261576 | Icona Hip Stem | Corin, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | MEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261576) |
| August 10, 2026 | K253794 | Prostate Core | Lucida Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253794) |
| August 5, 2026 | K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use... | Convatec | United Kingdom | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260737) |
| July 24, 2026 | K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | United Kingdom | Substantially Equivalent | 510(k) traditional | JTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261781) |
| July 24, 2026 | K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260598) |
| July 8, 2026 | K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260700) |
| June 24, 2026 | K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253263) |
| June 22, 2026 | K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253421) |
| June 12, 2026 | K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260406) |
| June 3, 2026 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260715) |
| May 27, 2026 | K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260646) |
| May 8, 2026 | DEN250013 | Modius Spero | Neurovalens Limited | United Kingdom | Unknown | De Novo | SHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250013) |
| April 15, 2026 | K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | CDZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252728) |
| April 10, 2026 | K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 1987 Media Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | OBR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252485) |
| April 1, 2026 | K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252943) |
| March 18, 2026 | K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253012) |
| March 9, 2026 | K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253413) |
| February 26, 2026 | K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede... | Speciality Fibres and Materials Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251700) |
| February 18, 2026 | K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253539) |
| February 17, 2026 | K251680 | Biosteon® Screw | Biocomposites, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | MAI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251680) |
| February 13, 2026 | K251742 | VELO Respiratory Test | Lex Diagnostics Limited | United Kingdom | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251742) |
| February 2, 2026 | K251200 | Vital Signs | Oxehealth Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QME | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251200) |
| January 23, 2026 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | DJG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250741) |
| January 16, 2026 | K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | United Kingdom | Substantially Equivalent | 510(k) traditional | BTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251448) |
| December 19, 2025 | K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | United Kingdom | Substantially Equivalent | 510(k) special | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253733) |
| December 19, 2025 | K252670 | Alzevita | Topia Medtech Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252670) |
| December 16, 2025 | K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | SCV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252111) |
| December 5, 2025 | K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | United Kingdom | Substantially Equivalent | 510(k) traditional | JTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251337) |
| November 26, 2025 | K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | JSM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242976) |
| November 6, 2025 | K252133 | Adaptix Ortho350 | Adaptix Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | IZF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252133) |
| October 20, 2025 | K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | DSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252277) |
| October 17, 2025 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | SGG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250159) |
| October 17, 2025 | DEN240076 | Modius Lean | Neurovalens Limited | United Kingdom | Unknown | De Novo | SFW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240076) |
| October 9, 2025 | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | FER | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250645) |
| September 19, 2025 | K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | HGM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250777) |
| September 19, 2025 | DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | United Kingdom | Unknown | De Novo | SFS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240067) |
| September 18, 2025 | K250369 | Axial3D Insight | Axial Medical Printing Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250369) |
| September 12, 2025 | K252586 | CADDIE | Odin Medical Limited | United Kingdom | Substantially Equivalent | 510(k) special | QNP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252586) |
| September 11, 2025 | K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251826) |
| September 9, 2025 | K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) special | ONN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252524) |
| September 2, 2025 | K251408 | OsteoSight™ Hip (v1) | Naitive Technologies, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | SAO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251408) |
| August 27, 2025 | K243687 | Vital Signs | Oxehealth Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QME | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243687) |
| August 26, 2025 | K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251983) |
| August 14, 2025 | K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | FMZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243437) |
| August 8, 2025 | K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | NEY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250718) |
| August 7, 2025 | K250622 | Succession™ AFN System | Ortho Solutions UK , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250622) |
| July 15, 2025 | K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QUW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242237) |
| July 8, 2025 | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240908) |
| July 3, 2025 | K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250286) |
| July 1, 2025 | K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12)... | Convatec | United Kingdom | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250699) |
| June 30, 2025 | K250670 | EchoConfidence (USA) | Mycardium AI Limited | United Kingdom | Substantially Equivalent | 510(k) abbreviated | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250670) |
| June 24, 2025 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | United Kingdom | Substantially Equivalent | 510(k) traditional | SFE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250268) |
| June 12, 2025 | K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | United Kingdom | Substantially Equivalent | 510(k) traditional | JTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250789) |
| June 12, 2025 | K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | KWL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242865) |
| June 6, 2025 | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure... | Convatec Limited | United Kingdom | Unknown | 510(k) special | FCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250891) |
| June 6, 2025 | K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242774) |
| May 23, 2025 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DFH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250549) |
| May 22, 2025 | DEN240035 | ConcizuTrace™ ELISA | Randox Laboratories, Ltd. | United Kingdom | Unknown | De Novo | SES | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240035) |
| May 20, 2025 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video... | Flexicare Medical Limited. | United Kingdom | Substantially Equivalent | 510(k) traditional | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250243) |
| May 19, 2025 | K243301 | MapRT | Vision Rt, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243301) |
| May 9, 2025 | K242732 | Tristel OPH | Tristel Solutions , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | QWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242732) |
| May 8, 2025 | K243110 | eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243110) |
| April 25, 2025 | K250153 | Neu Platform | Neuhealth Digital , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | GYD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250153) |
| April 18, 2025 | K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | ONE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250224) |
| April 16, 2025 | K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | LEL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243513) |
| April 8, 2025 | K242552 | Horos Mobile | Icat Solutions, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242552) |
| April 7, 2025 | K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250521) |
| April 2, 2025 | K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | QNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250138) |
| April 2, 2025 | K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | United Kingdom | Substantially Equivalent | 510(k) traditional | HDR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242031) |
| March 28, 2025 | K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | United Kingdom | Substantially Equivalent | 510(k) traditional | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243228) |
| March 19, 2025 | K243092 | AcuPebble Ox (200) | Acurable Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243092) |
| March 17, 2025 | K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with... | The Magstim Company Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243869) |
| February 28, 2025 | K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241717) |
| February 27, 2025 | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241550) |
| February 21, 2025 | K243330 | LYMA Laser PRO | Lyma Life , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243330) |
| February 20, 2025 | K242240 | CaRi-Plaque | Caristo Diagnostics , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242240) |
| February 19, 2025 | K242411 | Brainomix 360 e-Lung | Brainomix Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242411) |
| February 18, 2025 | K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with... | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243576) |
| February 14, 2025 | K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | POK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243294) |
| February 5, 2025 | K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) special | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242983) |
| February 3, 2025 | K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | HGM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241368) |
| January 31, 2025 | K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242442) |
| January 16, 2025 | K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241176) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Smith & Nephew Medical, Ltd. | 6 | October 30, 2026 |
| Brainomix Limited | 5 | June 12, 2026 |
| Flexicare Medical Limited. | 3 | September 2, 2026 |
| Convatec | 3 | August 5, 2026 |
| Thermo Fisher Scientific (Oxoid Ltd.) | 3 | July 24, 2026 |
| Biocomposites, Ltd. | 3 | February 17, 2026 |
| Naitive Technologies, Ltd. | 2 | October 27, 2026 |
| Rhythm AI, Ltd. | 2 | October 23, 2026 |
| Cmr Surgical Limited | 2 | October 21, 2026 |
| Cyden Limited | 2 | September 25, 2026 |
| Corin, Ltd. | 2 | September 17, 2026 |
| Odin Medical Limited | 2 | September 12, 2026 |
| iSMART Developments, Ltd. | 2 | July 24, 2026 |
| Neurovalens Limited | 2 | May 8, 2026 |
| Convatec Limited | 2 | April 1, 2026 |
| Vision Rt, Ltd. | 2 | March 18, 2026 |
| Axis-Shield Diagnostics, Ltd. | 2 | February 18, 2026 |
| Oxehealth Limited | 2 | February 2, 2026 |
| The Binding Site Group , Ltd. | 2 | October 17, 2025 |
| Huntleigh Healthcare , Ltd. | 2 | September 19, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 21 | October 27, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 19 | October 30, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 11 | October 27, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 11 | September 12, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 7 | September 17, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 7 | August 20, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 5 | October 26, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 5 | July 24, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 4 | September 16, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 4 | September 4, 2026 |
| Unknown | 3 | April 10, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 3 | September 19, 2025 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 3 | August 14, 2025 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 2 | September 19, 2025 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | September 2, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 1 | January 23, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | May 8, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 1 | February 28, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 92 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 10 | October 23, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 4 | May 8, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | June 30, 2025 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 1 | February 13, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).