# FDA device clearances in Japan: 153 since Nov 2024

Updated October 16, 2026.

FDA made 153 device decisions for applicants in Japan from November 21, 2024 to October 16, 2026: 153 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 41 applicants. The newest, K260605 on October 16, 2026, is Lilium one (USM330) from Lilium Otsuka Co., Ltd..

## The full list

FDA device clearances for applicants in Japan: 153 rows for $7.65, 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 8 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/japan

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: 153
- 510(k) and De Novo: 153
- PMA: 0
- Latest decision: October 16, 2026

## Newest decisions

The newest 100 of 153, 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 16, 2026 | K260605 | Lilium one (USM330) | Lilium Otsuka Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260605) |
| October 9, 2026 | K262902 | ECHELON Synergy | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262902) |
| October 6, 2026 | K262516 | TSK OptiXion | Tsk Laboratory, Japan | Japan | Substantially Equivalent | 510(k) traditional | QYM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262516) |
| September 23, 2026 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | EFB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262144) |
| September 18, 2026 | K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | Japan | Substantially Equivalent | 510(k) traditional | HJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262637) |
| September 18, 2026 | K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261229) |
| September 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | Japan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262495) |
| September 16, 2026 | K261283 | APERTO Lucent MRI System | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261283) |
| September 11, 2026 | K262397 | CuratOR EX2742 | Eizo Corporation | Japan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262397) |
| September 11, 2026 | K261255 | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | Japan | Substantially Equivalent | 510(k) traditional | MYC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261255) |
| September 10, 2026 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | FET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262079) |
| September 4, 2026 | K253836 | FCT iStream Phase 2 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253836) |
| September 3, 2026 | K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261281) |
| September 1, 2026 | K262783 | RadiForce MX247W | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262783) |
| August 27, 2026 | K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260856) |
| August 27, 2026 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260824) |
| August 27, 2026 | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | PSV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260401) |
| August 26, 2026 | K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | Japan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260972) |
| August 13, 2026 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | Japan | Substantially Equivalent | 510(k) traditional | LPN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253795) |
| August 12, 2026 | K261170 | BA-004CC | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | ITX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261170) |
| August 12, 2026 | K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | Japan | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251641) |
| August 7, 2026 | K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) special | QNP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260567) |
| July 31, 2026 | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | ODG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261183) |
| July 22, 2026 | K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | Japan | Substantially Equivalent | 510(k) abbreviated | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260964) |
| July 15, 2026 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | Japan | Substantially Equivalent | 510(k) abbreviated | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253606) |
| July 2, 2026 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) special | FET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261880) |
| July 1, 2026 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated... | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254056) |
| June 24, 2026 | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261260) |
| June 16, 2026 | K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | EOQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253137) |
| June 12, 2026 | K261175 | WHILL (WHILL Model C2) | Whill, Inc. | Japan | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261175) |
| June 11, 2026 | K260174 | PROBEAT-CR | Hitachi High-Tech Corp. | Japan | Substantially Equivalent | 510(k) traditional | LHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260174) |
| May 27, 2026 | K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | OEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254075) |
| May 21, 2026 | K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip... | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260580) |
| May 20, 2026 | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253596) |
| May 15, 2026 | K253935 | medXion NEXUS | medXion Technologies, Inc. | Japan | Substantially Equivalent | 510(k) traditional | OAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253935) |
| May 11, 2026 | K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | QJP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254178) |
| May 6, 2026 | K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | Japan | Substantially Equivalent | 510(k) traditional | DXQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260747) |
| April 30, 2026 | K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254189) |
| April 30, 2026 | K252503 | Intelligent NR | Canon, Inc. | Japan | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252503) |
| April 28, 2026 | K260248 | Ultra-Fast Warm | Kitazato Corporation | Japan | Substantially Equivalent | 510(k) traditional | MQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260248) |
| April 23, 2026 | K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS... | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | EOQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252341) |
| April 6, 2026 | K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | Japan | Substantially Equivalent | 510(k) traditional | EBD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254091) |
| April 6, 2026 | K253862 | APERTO Lucent MRI System | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253862) |
| March 31, 2026 | K253029 | RW-1 | Mediott, Inc. | Japan | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253029) |
| March 27, 2026 | K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253625) |
| March 27, 2026 | K252295 | Ryurei | Terumo Corporation | Japan | Substantially Equivalent | 510(k) traditional | LOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252295) |
| March 24, 2026 | K252099 | Trinias | Shimadzu Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252099) |
| March 23, 2026 | K253686 | True Definition DL | Ge Healthcare Japan Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253686) |
| March 20, 2026 | K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire... | FMD Co., Ltd. | Japan | Substantially Equivalent | 510(k) special | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260544) |
| March 20, 2026 | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | EOB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252050) |
| March 19, 2026 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252101) |
| March 18, 2026 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | LBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260830) |
| March 10, 2026 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. | Japan | Substantially Equivalent | 510(k) traditional | ELC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260773) |
| March 10, 2026 | K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253584) |
| March 9, 2026 | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251861) |
| March 6, 2026 | K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | KGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251807) |
| February 22, 2026 | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | FDT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253646) |
| February 17, 2026 | K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250550) |
| February 6, 2026 | K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) special | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253568) |
| February 2, 2026 | K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252011) |
| January 20, 2026 | K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253597) |
| December 23, 2025 | K254163 | VarioSurg 4 | Nakanishi, Inc. | Japan | Substantially Equivalent | 510(k) traditional | DZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254163) |
| December 18, 2025 | K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | Japan | Substantially Equivalent | 510(k) traditional | MXK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252348) |
| December 18, 2025 | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250993) |
| December 12, 2025 | K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | EOQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250863) |
| December 1, 2025 | K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | KPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251370) |
| November 26, 2025 | K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | Japan | Substantially Equivalent | 510(k) traditional | PTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252355) |
| November 25, 2025 | K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252889) |
| November 21, 2025 | K250700 | Pen Injector Needle 32.5 | Terumo Corporation | Japan | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250700) |
| November 12, 2025 | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus... | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251336) |
| November 7, 2025 | K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Japan | Substantially Equivalent | 510(k) traditional | HKX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253039) |
| October 31, 2025 | K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252074) |
| October 29, 2025 | K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Japan | Substantially Equivalent | 510(k) traditional | NFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250618) |
| October 24, 2025 | K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | FCG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252646) |
| October 21, 2025 | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250409) |
| October 17, 2025 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V... | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250945) |
| October 16, 2025 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector... | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252247) |
| October 10, 2025 | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251602) |
| October 10, 2025 | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use... | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250351) |
| October 9, 2025 | K251876 | cleadew GP hydra one | Ophtecs Corporation | Japan | Substantially Equivalent | 510(k) traditional | MRC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251876) |
| October 9, 2025 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator... | Nihon Kohden Corporation | Japan | Substantially Equivalent | 510(k) traditional | OLT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251366) |
| October 7, 2025 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with... | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252150) |
| October 7, 2025 | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | KGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250187) |
| October 3, 2025 | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | ODG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251859) |
| September 26, 2025 | K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | OCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251986) |
| September 26, 2025 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251645) |
| September 25, 2025 | K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | OCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251997) |
| September 19, 2025 | K252662 | UniBur | Nakanishi, Inc. | Japan | Substantially Equivalent | 510(k) traditional | HBE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252662) |
| September 19, 2025 | K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | FDT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251867) |
| September 19, 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER... | Nakanishi, Inc. | Japan | Substantially Equivalent | 510(k) traditional | ELC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251689) |
| September 18, 2025 | K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | ITX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250883) |
| September 17, 2025 | K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX... | Kamemizu Chemical Industry Co., Ltd. | Japan | Substantially Equivalent | 510(k) traditional | EBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252035) |
| September 17, 2025 | K251386 | ECHELON Synergy | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251386) |
| August 28, 2025 | K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252030) |
| August 26, 2025 | K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | Japan | Substantially Equivalent | 510(k) traditional | MQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251305) |
| August 11, 2025 | K232456 | RW-1 | Mediott, Inc. | Japan | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232456) |
| July 30, 2025 | K250127 | TSK Syringe | Tsk Laboratory, Japan | Japan | Substantially Equivalent | 510(k) traditional | QNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250127) |
| July 29, 2025 | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | KTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251664) |
| July 24, 2025 | K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | Japan | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250284) |
| July 22, 2025 | K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250901) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Olympus Medical Systems Corporation | 28 | August 27, 2026 |
| Fujifilm Corporation | 22 | October 9, 2026 |
| Olympus Medical Systems Corp. | 16 | September 10, 2026 |
| Canon Medical Systems Corporation | 14 | May 20, 2026 |
| Asahi Intecc Co., Ltd. | 10 | May 11, 2026 |
| Eizo Corporation | 5 | September 11, 2026 |
| Nihon Kohden Corporation | 4 | August 12, 2026 |
| Terumo Corporation | 4 | March 27, 2026 |
| Nakanishi, Inc. | 4 | March 10, 2026 |
| Tsk Laboratory, Japan | 3 | October 6, 2026 |
| Nikkiso Co., Ltd. | 3 | May 15, 2025 |
| Topcon Corporation | 2 | September 18, 2026 |
| Menicon Co, Ltd. | 2 | September 17, 2026 |
| Hamamatsu Photonics K.K. | 2 | July 22, 2026 |
| Whill, Inc. | 2 | June 12, 2026 |
| Kitazato Corporation | 2 | April 28, 2026 |
| Mediott, Inc. | 2 | March 31, 2026 |
| Tomey Corporation | 2 | December 18, 2025 |
| Sb-Kawasumi Laboratories, Inc. | 2 | November 26, 2025 |
| Ya-Man, Ltd. | 2 | October 29, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 43 | September 11, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 42 | October 16, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 17 | September 3, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 12 | June 16, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 8 | September 23, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 8 | September 18, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 5 | October 6, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 4 | October 29, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 3 | July 22, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | June 12, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 3 | April 28, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 2 | August 12, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 2 | July 1, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 1 | December 5, 2024 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 136 | October 16, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 10 | August 7, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 7 | September 1, 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/).