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 |
|---|---|---|---|---|---|
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc | JDQ | Class II | |
| K232942 | G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | |
| K232432 | E3D™-A Interbody System | Evolution Spine, LLC | OVD | Class II | |
| K231910 | DermRays Revive | Wuhan Lotuxs Technology Co.,Ltd. | GEX | Class II | |
| K231343 | Redemption Duo Hindfoot Nail System | Vilex LLC | HSB | Class II | |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC. | JXI | Class II | |
| K233394 | Gem Flow Now (GEM2770-FN) | SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) | IYN | Class II | |
| K233224 | Epilaser Pro | Epilady 2000, LLC | GEX | Class II | |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories, LLC | KNT | Class II | |
| K234118 | CentriMag™ Acute Circulatory Support System | Abbott Medical | QNR | Class II | |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc | PLF | Class II | |
| K234109 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | |
| K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Anhui Intco Medical Products Co., Ltd. | LZA | Class I | |
| K233508 | iFuse Bedrock Granite® Implant System | SI-Bone, Inc. | OUR | Class II | |
| K233485 | M-Wave | Altivera Medical, Inc. | IPF | Class II | |
| K233299 | ExactechGPS® System | Blue Ortho | OLO | Class II | |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co.,Ltd. | LCX | Class II | |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co.,Ltd | PKL | Class II | |
| K232182 | One-Fil | Mediclus Co., Ltd | KIF | Class II | |
| K231785 | Perifit Pump | X6 Innovations | HGX | Class II | |
| K231715 | MONDRIAN™ Anterior Lumbar Plate System | CTL Medical Corporation | KWQ | Class II | |
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | LSL | Class II | |
| K231303 | Arm-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K231282 | LifeOutcomes C-Quest™ Blood Culture Sampling Device | Lifeoutcomes, LLC | JKA | Class II | |
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. | LPL | Class II | |
| K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Corp. | MBI | Class II | |
| K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K233714 | BreView | GE Medical Systems SCS | LLZ | Class II | |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | Sutter Medizintechnik GmbH | GEI | Class II | |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC. | QRL | Class II | |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | ConvaTec Limited | EZD | Class II | |
| K232417 | Mr Q; Mr Q Supine; Mr Q Slt | Meridian AG | HQF | Class II | |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Nobel Biocare AB | NHA | Class II | |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | |
| K231607 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | LLZ | Class II | |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site | DFH | Class II | |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | EZL | Class II | |
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | QUA | Class II | |
| K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | |
| K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | |
| K231305 | Endoform Dental Membrane | AROA Biosurgery Inc. | NPL | Class II | |
| K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | QVF | Class II | |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | NEU | Class II | |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | restor3d, Inc. | MAX | Class II | |
| K233887 | IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | Megagen Implant Co., Ltd. | NHA | Class II | |
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | Shenzhen Roundwhale Technology Co. Ltd. | NUH | Class II | |
| K231299 | Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector | Cair LGL | PIO | Class II | |
| K230841 | NailLift | Jps Corporation | MQZ | Unclassified | |
| K233105 | RESPONSE™ Rib and Pelvic System | Orthopediatrics Corp | MDI | Class II |