510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K253505 | Zamenix™ P | Roen Surgical, Inc. | FGB | Class II | |
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems | QWB | Class II | |
| K252571 | mdprostate | Mediaire GmbH | QIH | Class II | |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | EIA | Class I | |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp., dba Stryker Orthopaedics | KRO | Class II | |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | IOR | Class I | |
| K261121 | Megalodon Dynamic Compression System | Paragon 28 | JDR | Class II | |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet | MYN | Class II | |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular | MOF | Class II | |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | Qiagen | PAM | Class II | |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | NHA | Class II | |
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical US LLC | FIE | Class II | |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | MHX | Class II | |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | EZL | Class II | |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | HAW | Class II | |
| K261456 | Ruthinium Disc | Dental Manufacturing SpA | POW | Class II | |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | QKQ | Class II | |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical, Ltd. | KNY | Class II | |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | MMK | Class II | |
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | ConvaTec Limited | EZD | Class II | |
| K260120 | NaturaJel™ Oral Wound Care Kit | HCS Innovation, LLC | OLR | Unclassified | |
| K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio | |||
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation Ltd | HWC | Class II | |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | QNP | Class II | |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | |
| K261523 | Vertex™ Thrombectomy System | Jupiter Endovascular | QEW | Class II | |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | OHS | Class II | |
| K260572 | Marrow Marxman | Medimetrix, LLC | KNW | Class II | |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | LPH | Class II | |
| K253902 | RealGUIDE | 3DIEMME SRL | QIH | Class II | |
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | MRH | Class II | |
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | Acist Medical Systems, Inc. | IZQ | Class II | |
| K262047 | Grappler Suture Anchor System | Paragon 28 | MBI | Class II | |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K261504 | PuraStat-RM | 3-D Matrix, Inc. | PHN | Unclassified | |
| K261503 | PuraStat GI | 3-D Matrix, Inc. | QAU | Class II | |
| K261408 | SABER-XA System | Elevation Spine | OVD | Class II | |
| K260381 | Eve | Wandercraft | PHL | Class II | |
| K260236 | Xlite | Gemss Healthcare Co., Ltd. | IZL | Class II | |
| K262681 | NanoCeram Resin | 3BFAB Teknoloji A.S. | EBI | Class II | |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | OrthAlign, Inc. | ONN | Class II | |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | JWH | Class II | |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | LRK | Class II | |
| K261854 | xvision Spine system | Augmedics Ltd. | SBF | Class II | |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | MQP | Class II | |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | OVD | Class II | |
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | DQD | Class II | |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | LED Intellectual Properties LLC | OHS | Class II |