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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K943623 | Pq5000 CT System | Philips North America LLC | JAK | Class II | |
| K943157 | Oral-B Ultrafloss with Flluoride | Oral-B Laboratories | JES | Class I | |
| K942690 | Ranir Dental Tape Mint Waxed with Fluoride | Ranir/Dcp Corp. | JES | Class I | |
| K942689 | Ranir Dental Floss Mint Waxed with Fluoride | Ranir/Dcp Corp. | JES | Class I | |
| K942633 | Oral-B Interdental Woodsticks with Fluoride | Oral-B Laboratories | JET | Class I | |
| K933544 | Fujinon Video Laporascope | FUJIFILM Healthcare Americas Corporation | HIH | Class II | |
| K951351 | X2000 Traditional Wheelchair | Homecrest Industries | IOR | Class I | |
| K950367 | IV Shuttle | Equipment Concepts, Inc. | FOX | Class I | |
| K946346 | Acufex Tag(r) Bioabsorbable Anchors | Acufex Microsurgical, Inc. | JDR | Class II | |
| K945524 | Cordis Introducing Catheter | Cordis US Corp. | DYB | Class II | |
| K945257 | 577Es (Ergosense) | Lumex, Inc. | INO | Class II | |
| K945064 | Selby Instrumentation | Advanced Spine Fixation Systems, Inc. | MNH | Class II | |
| K944989 | Noprofile Olbert Catheter System | Meadox Medicals, Div. Boston Scientific Corp. | LIT | Class II | |
| K944792 | Zimmer Monobloc Hip Prosthesis with Poly (Methyl Methacrylate) | Zimmer GmbH | JDI | Class II | |
| K944725 | Kis-II Str Fixtures | Implant Center of the Palm Beaches | DZE | Class II | |
| K944412 | The Breather | Pal Medical, Inc. | BWF | Class II | |
| K944369 | New-Stim Spinal Adjustment Instrument | Lawrence E. Newsum, DC | LXM | Unclassified | |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release Sy | Orthomet, Inc. | LXH | Class I | |
| K943775 | Selby Instrumentation | Advanced Spine Fixation Systems, Inc. | MNH | Class II | |
| K943596 | Vantage, for Adac Gamma Cameras | Philips North America LLC | KPS | Class II | |
| K942159 | Novopen 1.5 | Novo Nordisk Pharmaceuticals, Inc. | FMF | Class II | |
| K941713 | Ortho-Mune 0Kt 11 (Cd2) Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K935748 | Ortho Recombiplastin II W/ortho Recombiplastin II Diluent | Ortho Diagnostic Systems, Inc. | GJS | Class II | |
| K935020 | Omni-Trac Modification | Invivo Research, Inc. | MLD | Class II | |
| K932532 | Ortho-Mune Okt8 (Cd8) Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K932531 | Ortho-Mune Okt 4 (Cd4) Monoclonal Antibody Murine | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K932530 | Ortho-Mune Okt 3 Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K951713 | Button Lubricator | Fibertech Instruments, Inc. | FHX | Class II | |
| K951488 | Kendall Curity Catheter Plug with Protective Cap | The Kendal Co. | KNY | Class II | |
| K951444 | Endopath Optical Access Needkle | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K951342 | Q4.5-5.0Pb-4.5 | Central Solutions, Inc. | LRJ | Class I | |
| K951328 | Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with Cord | Labeltape Meditect, Inc. | GEI | Class II | |
| K951317 | Pheno-Cen Spray Disinfectant Deodorant | Central Solutions, Inc. | LRJ | Class I | |
| K951252 | Karl Storz Pediatric Pyloric Spreader, Pylorotome, Endotome | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K951123 | Cavicide Surface Disinfectant/decontaminant Cleaner | Micro-Aseptic Products, Inc. | LRJ | Class I | |
| K950817 | Dried Gram Positive Mic/combo Panels/pneumococci | Baxter Diagnostics, Inc. | JWY | Class II | |
| K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | DPS | Class II | |
| K950754 | Macro Suction Tube Model No 10061 | Dlp, Inc. | GCY | Class I | |
| K950619 | Bioderm Medical Foam Wound Dressing | Bioderm, Inc. | KMF | Class I | |
| K950612 | Endoscopes and Accessories | Storz Instrument Co. | GCJ | Class II | |
| K950610 | Fiko Fo;, Tjer,a; O,ager Fto-1000 | FUJIFILM Healthcare Americas Corporation | LMC | Class II | |
| K950504 | Perval Surgical Gown (Marketing Name) | Standard Textile Co., Inc. | FYA | Class II | |
| K950468 | Powder Free Sterile Latex Surgeons Gloves | Intl. Trade Management Co. | KGO | Class I | |
| K950467 | Powder Free Patient Examination Gloves | Intl. Trade Management Co. | LYY | Class I | |
| K950464 | Sscor/board ..3 Model 23000 Pre-Assembled Suction System for Patient Transport Vehicles | Sscor | GCX | Class II | |
| K946111 | Proshield Plus Multiple | Sino (U.S.A.) Co. | LYY | Class I | |
| K945526 | Lunar Expert | Lunar Corp. | KGI | Class II | |
| K945223 | Orex Isolation Gown | Thantex Specialties, Inc. | FYC | Class II | |
| K944053 | Natural Rubber Latex Surgeons Glove | Arent Fox | KGO | Class I | |
| K943411 | Accucure 3000 | Lasermed Corp. | GEX | Class II |