# FDA device clearances in Colorado: 135 since Nov 2024

Updated October 30, 2026.

FDA made 135 device decisions for applicants in Colorado from November 13, 2024 to October 30, 2026: 82 510(k) clearances and De Novo grants and 53 PMA approvals and supplements, for 45 applicants. The newest, K263587 on October 30, 2026, is Arctic Sun™ Neonatal ArcticGel™ Pad from Medivance, Inc..

## The full list

FDA device clearances for applicants in Colorado: 135 rows for $6.75, 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/state/colorado

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: 135
- 510(k) and De Novo: 82
- PMA: 53
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 135, 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 | K263587 | Arctic Sun™ Neonatal ArcticGel™ Pad | Medivance, Inc. | Colorado | Substantially Equivalent | 510(k) special | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263587) |
| October 30, 2026 | K262685 | Zirconia Collective 4Y Dental Zirconia Blank | Zirconia Collective, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262685) |
| October 29, 2026 | K262839 | Cleerly ISCHEMIA | Cleerly, Inc. | Colorado | Substantially Equivalent | 510(k) special | QXZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262839) |
| October 27, 2026 | K260909 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation &... | Sienco, Inc. | Colorado | Substantially Equivalent | 510(k) special | JPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260909) |
| October 9, 2026 | K262301 | Rapid ICH (v4.0) | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262301) |
| October 7, 2026 | K261120 | APEX 3D S Diamond Tibia | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | HSN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261120) |
| September 28, 2026 | P970051/S244 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S244) |
| September 28, 2026 | P890027/S067 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P890027S067) |
| September 28, 2026 | P840024/S099 | Nucleus® 22 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840024S099) |
| September 28, 2026 | P130016/S061 | Cochlear Hybrid Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | PGQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130016S061) |
| September 28, 2026 | P000015/S057 | Cochlear Auditory Brainstem Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MHE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000015S057) |
| September 21, 2026 | K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261368) |
| September 21, 2026 | K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | Colorado | Substantially Equivalent | 510(k) traditional | KRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253509) |
| September 17, 2026 | P250028/S003 | Synergy Disc | Synergy Spine Solutions, Inc. | Colorado | Approved | PMA real-time process supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028S003) |
| September 16, 2026 | P240001/S003 | PearlMatrixTM Peptide Enhanced Bone Graft | Cerapedics, Inc. | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240001S003) |
| September 16, 2026 | P180014/S014 | XPS™ with Steen Solution™ Perfusate | Xvivo Perfusion, Inc. | Colorado | Approved | PMA real-time process supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180014S014) |
| September 16, 2026 | P140019/S014 | i-F ACTOR® Peptide Enhanced Graft Substitute | Cerapedics, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140019S014) |
| September 16, 2026 | P110009/S040 | Mobi-C® Cervical Disc Prosthesis for use at Two Levels | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110009S040) |
| September 16, 2026 | P110002/S040 | Mobi-C® Cervical Disc Prosthesis for use at One Level | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110002S040) |
| September 15, 2026 | K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261070) |
| August 28, 2026 | K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) special | HTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262722) |
| August 21, 2026 | P910001/S127 | Philips Laser System | Spectranetics Corp. | Colorado | 30-day notice accepted | PMA 30-day notice | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S127) |
| August 14, 2026 | P910001/S126 | ELCA Coronary Laser Atherectomy Catheters | Spectranetics Corp. | Colorado | Approved | PMA 135-day supplement | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S126) |
| August 6, 2026 | K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | JDR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261121) |
| August 3, 2026 | K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262047) |
| July 29, 2026 | K261210 | Cleerly Plaque | Cleerly, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261210) |
| July 29, 2026 | K260588 | Cleerly LABS | Cleerly, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260588) |
| July 13, 2026 | K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | Colorado | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261085) |
| July 10, 2026 | K260902 | Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™... | Cochlear Americas | Colorado | Substantially Equivalent | 510(k) traditional | PFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260902) |
| July 6, 2026 | P250028/S002 | Synergy Disc | Synergy Spine Solutions, Inc. | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028S002) |
| June 25, 2026 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | Colorado | Substantially Equivalent | 510(k) traditional | PDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260992) |
| June 25, 2026 | K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | Colorado | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260231) |
| June 24, 2026 | K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261023) |
| June 18, 2026 | P220016 | HepQuant SHUNT® Liver Diagnostic Test | Hepquant, LLC | Colorado | Approved | PMA original approval | SIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220016) |
| June 11, 2026 | K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Colorado | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260322) |
| June 3, 2026 | K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | DZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261826) |
| May 22, 2026 | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | PZX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252917) |
| May 1, 2026 | K260314 | Ancora-SB | Aspero Medical, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | FDA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260314) |
| May 1, 2026 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253030) |
| April 30, 2026 | P970051/S242 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S242) |
| April 30, 2026 | P130016/S060 | Cochlear Hybrid Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | PGQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130016S060) |
| April 30, 2026 | P000015/S056 | Cochlear Auditory Brainstem Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MHE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000015S056) |
| April 22, 2026 | K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD)... | Steritec Products | Colorado | Substantially Equivalent | 510(k) traditional | QVB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252306) |
| April 9, 2026 | P250028/S001 | Synergy Disc | Synergy Spine Solutions, Inc. | Colorado | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028S001) |
| April 7, 2026 | P240001/S002 | PearlMatrix™ Peptide Enhanced Bone Graft | Cerapedics, Inc. | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240001S002) |
| April 7, 2026 | P140019/S013 | i-FACTOR® Peptide Enhanced Graft Substitute | Cerapedics, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140019S013) |
| March 27, 2026 | K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QLQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253392) |
| March 26, 2026 | K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | HAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253379) |
| March 23, 2026 | P110009/S038 | Mobi-C® P&F Cervical Disc Prosthesis | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110009S038) |
| March 23, 2026 | P110002/S038 | Mobi-C® Cervical Disc Prosthesis | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110002S038) |
| March 17, 2026 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253886) |
| March 16, 2026 | K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | PGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253395) |
| March 13, 2026 | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560)... | Medtronic Navigation, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | ONO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253391) |
| March 11, 2026 | K250937 | Venous Return Cannulae | LivaNova USA, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250937) |
| March 5, 2026 | K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253591) |
| February 26, 2026 | P250028 | Synergy Disc | Synergy Spine Solutions, Inc. | Colorado | Approved | PMA original approval | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028) |
| February 25, 2026 | K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | Colorado | Substantially Equivalent | 510(k) traditional | PQC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253472) |
| February 24, 2026 | K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | Colorado | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253714) |
| February 12, 2026 | K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253381) |
| February 11, 2026 | DEN250007 | Delivery Date AI | Ultrasound AI | Colorado | Unknown | De Novo | SHE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250007) |
| February 6, 2026 | P910001/S124 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | Colorado | Approved | PMA 135-day supplement | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S124) |
| January 29, 2026 | P120024/S014 | activL Artificial Disc | Highridge Medical, LLC | Colorado | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120024S014) |
| January 16, 2026 | DEN250005 | Sana Device | Sana Health | Colorado | Unknown | De Novo | QYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250005) |
| January 12, 2026 | K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | Colorado | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252962) |
| December 29, 2025 | K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula... | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | JOH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251313) |
| December 29, 2025 | K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | BZT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251025) |
| December 19, 2025 | P970051/S240 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S240) |
| December 19, 2025 | K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) special | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253613) |
| December 18, 2025 | P960042/S073 | GlideLight Laser Sheath | Spectranetics (Philips) | Colorado | 30-day notice accepted | PMA 30-day notice | MFA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960042S073) |
| December 18, 2025 | P910001/S125 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | Colorado | 30-day notice accepted | PMA 30-day notice | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S125) |
| December 17, 2025 | K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | Colorado | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253093) |
| December 11, 2025 | P240001/S001 | PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) | Cerapedics, Inc. | Colorado | Approved | PMA 180-day supplement | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240001S001) |
| December 5, 2025 | K252296 | OncoPatch | Oncopatch, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | KXK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252296) |
| December 5, 2025 | K250711 | VSP Orthopedics System | 3D Systems, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | PBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250711) |
| December 2, 2025 | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Colorado | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252103) |
| November 25, 2025 | P180014/S013 | XPS™ with Steen Solution™ Perfusate | Xvivo Perfusion, Inc. | Colorado | Approved | PMA real-time process supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180014S013) |
| November 3, 2025 | K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Colorado | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251532) |
| October 29, 2025 | P110009/S037 | LDR Spine Mobi-C® Cervical Disc Prosthesis | Highridge Medical, LLC | Colorado | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110009S037) |
| October 29, 2025 | P110002/S037 | LDR Spine Mobi-C® Cervical Disc Prosthesis | Highridge Medical, LLC | Colorado | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110002S037) |
| October 24, 2025 | K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251974) |
| October 17, 2025 | K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251282) |
| October 16, 2025 | P970051/S236 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | Approved | PMA real-time process supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S236) |
| October 16, 2025 | P130016/S058 | Nucleus® Hybrid™ L24 Cochlear Implant System | Cochlear Americas | Colorado | Approved | PMA real-time process supplement | PGQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130016S058) |
| October 6, 2025 | K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy... | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250173) |
| September 30, 2025 | K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252106) |
| September 26, 2025 | P970051/S238 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S238) |
| September 25, 2025 | K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube... | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243785) |
| September 23, 2025 | K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251987) |
| September 4, 2025 | K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251533) |
| September 2, 2025 | P970051/S237 | Cochlear™ Nucleus® System | Cochlear Americas | Colorado | Approved | PMA 180-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S237) |
| August 26, 2025 | K252526 | Rapid DeltaFuse | Ischemaview, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252526) |
| August 11, 2025 | K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251862) |
| August 6, 2025 | P970051/S235 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S235) |
| July 25, 2025 | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | KRH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250859) |
| July 24, 2025 | P970051/S234 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | 30-day notice accepted | PMA 30-day notice | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S234) |
| July 18, 2025 | K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250952) |
| July 16, 2025 | K251151 | Rapid CTA 360 | Ischemaview | Colorado | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251151) |
| July 14, 2025 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) special | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251850) |
| July 10, 2025 | K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | Colorado | Substantially Equivalent | 510(k) special | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250283) |
| July 3, 2025 | P970051/S225 | Nucleus® 24 Cochlear Implant System | Cochlear Americas | Colorado | Approved | PMA 180-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S225) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Cochlear Americas | 24 | September 28, 2026 |
| Paragon 28, Inc. | 12 | October 7, 2026 |
| Highridge Medical, LLC | 11 | September 16, 2026 |
| Ischemaview, Inc. | 7 | October 9, 2026 |
| Covidien, LLC | 6 | September 15, 2026 |
| Medtronic Navigation, Inc. | 6 | March 26, 2026 |
| Synergy Spine Solutions, Inc. | 5 | September 17, 2026 |
| Spectranetics Corp. | 5 | August 21, 2026 |
| Cleerly, Inc. | 4 | October 29, 2026 |
| Cerapedics, Inc. | 4 | September 16, 2026 |
| Mighty Oak Medical | 4 | June 11, 2026 |
| Medivance, Inc. | 3 | October 30, 2026 |
| Xvivo Perfusion, Inc. | 3 | September 16, 2026 |
| Cerapedics, LLC | 3 | September 16, 2026 |
| Promethean Restorative, LLC | 3 | January 12, 2026 |
| Circa Scientific, Inc. | 3 | May 1, 2025 |
| 3D Systems, Inc. | 2 | June 3, 2026 |
| Genesee Biomedical, Inc. | 2 | May 22, 2026 |
| LivaNova USA, Inc. | 2 | March 11, 2026 |
| Zirconia Collective, Inc. | 1 | October 30, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 40 | October 7, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 27 | September 28, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 20 | October 30, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 19 | October 9, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 6 | September 15, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 6 | March 26, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 5 | May 1, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 4 | September 16, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 2 | October 30, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 2 | April 22, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 1 | October 27, 2026 |
| Unknown | 1 | June 24, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 1 | June 18, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | January 16, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 64 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 28 | September 28, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 16 | October 30, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 11 | April 9, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 9 | September 17, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 3 | June 18, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 2 | August 14, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 2 | February 11, 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/).