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 |
|---|---|---|---|---|---|
| K964211 | Davol Plume Filter (5541420) | Davol Inc., Sub. C.R. Bard, Inc. | GEX | Class II | |
| K963906 | Patient Restraints | Safety Intl., Inc. | FMQ | Class I | |
| K963862 | Touch N' Heat | Sybron Dental Specialties, Inc. | EAT | Class II | |
| K963705 | Color Enhancement Function for the Ssa-380A | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K963547 | The Wrap Immobilization System | Safe Restraints, Inc. | FMQ | Class I | |
| K963517 | Spectra Science Biopsy Forceps | Spectrascience, Inc. | FCL | Class I | |
| K963341 | Midstream Onestep Pregnancy Home Test | Syntron Bioresearch, Inc. | LCX | Class II | |
| K963170 | Olympus Ferritin Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | DBF | Class II | |
| K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | FBN | Class II | |
| K964588 | Waters 515 Hplc Pump (515) | Waters Corporation | KIE | Class I | |
| K964269 | Playtex Tampons Gentle Glide Deordorant Tampons and Playtex/gentle Glide Deodorant Portables Tampons | Playtime Products, Inc. | HIL | Class II | |
| K963992 | Capillary Adaptor Accessory | Medica Corp. | CGZ | Class II | |
| K963964 | Avl Compact 3 Ph/blood Gas Analyzer | Avl Scientific Corp. | CHL | Class II | |
| K963902 | Quantitative Fibrinogen Assay | Ortho Diagnostic Systems, Inc. | GIS | Class II | |
| K963763 | Easylyte Sodium/potassium/chloride/lithium Analyzer | Medica Corp. | JGS | Class II | |
| K963753 | Nasp Transparent Dressing | North American Sterilization & Packaging Co. | MGP | Unclassified | |
| K963724 | Gauze Sponge, Non X-Ray Detectable | Grand Medical Products | EFQ | Unclassified | |
| K963693 | Ovusign - One-Step Home Ovulation Predictor Test | Princeton BioMeditech Corp. | CEP | Class I | |
| K963135 | Giardia Celisa | Techlab, Inc. | MHI | Class II | |
| K963011 | Lifestyle Frequency Progressive (Methafilcon a) Multifocal Hydrophilic Contact Lenses for Daily Wear | Permeable Technologies, Inc. | LPL | Class II | |
| K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical Co., Ltd. | LBK | Unclassified | |
| K962911 | Contact Lens with Color Additive | Cal Bionics | LPL | Class II | |
| K962760 | Enzymun-Test Ft3 | Boehringer Mannheim Corp. | CDP | Class II | |
| K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | LYL | Class II | |
| K953591 | Cep 8 Spectrumorange DNA Probe Kit | Vysis | OYU | Class II | |
| K953233 | Simview 3000 CT Option | Siemens Medical Solutions USA, Inc. | KPQ | Class II | |
| K964557 | Resound Bt4 Personal Hearing System W/remote Control Option | Resound Corp. | ESD | Class I | |
| K964530 | Dahlberg Hearing Aid with Multi-Channel Compression Circuit | Miracle-Ear, Inc. | ESD | Class I | |
| K964511 | Unitron Model Sound F/xd +4 (Sound F/xd +4) | Unitron Industries, Inc. | ESD | Class I | |
| K964510 | Unitron Model Icon Aohpd +4 (Icon Aohpd +4) | Unitron Industries, Inc. | ESD | Class I | |
| K964508 | Unitron Model Icon Aohp +4 (Icon Aohp +4) | Unitron Industries, Inc. | ESD | Class I | |
| K964504 | Unitron Model Icon Aohpl +4 | Unitron Industries, Inc. | ESD | Class I | |
| K964503 | Unitron Model Sound F/x +4 | Unitron Industries, Inc. | ESD | Class I | |
| K964502 | Unitron Model Sound F/xp +4 | Unitron Industries, Inc. | ESD | Class I | |
| K964451 | Piccolo K-Amp Vc+, Piccolo P-A1, Piccolo P-Ao and Piccolo Atc | Rexton, Inc. | ESD | Class I | |
| K964349 | Aia-Pack Folate Assay | Tosoh Medics, Inc. | CGN | Class II | |
| K964310 | Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (Gem.c010) | Johnson & Johnson Clinical Diagnostics, Inc. | CDP | Class II | |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (Gem.1025) and T3 Uptake Calibrators (Gem.c025) | Johnson & Johnson Clinical Diagnostics, Inc. | KHQ | Class II | |
| K964244 | Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing Aids | Starkey Laboratories, Inc. | ESD | Class I | |
| K964214 | Starkey a-13 Sequel Programmable, a-13 K-Amp Programmable Air Conduction Hearing Aids | Starkey Laboratories, Inc. | ESD | Class I | |
| K964144 | Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus Mf - Pcp-Mf | Para Scientific Co. | LIO | Class I | |
| K964109 | Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip | Microsurge, Inc. | FZP | Class II | |
| K964094 | Minifix | Ferguson Medical | KTT | Class II | |
| K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | OCW | Class II | |
| K963941 | The Pharaoh Compensating Filter | Octostop, Inc. | KPR | Class II | |
| K963875 | Ahs Omega K-Amp | Authorized Hearing Systems, Inc. | ESD | Class I | |
| K963805 | Prodigy Ac | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K963798 | Synthes Titanium Alloy Volar Distal Radius Plate (Ti Alloy Vdrp) System | Synthes (USA) Products LLC | HRS | Class II | |
| K963788 | Primofocus Compact | Oticon, Inc. | ESD | Class I | |
| K963735 | Cojet System | Espe GmbH & Co. KG. | EBF | Class II |