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 |
|---|---|---|---|---|---|
| K911744 | Precision Optics Corporation Laparoscope | Precise Optics | GCJ | Class II | |
| K911597 | The Needle Nabber | J. Simmons Instrument, Ltd. | FMI | Class II | |
| K911443 | Insul-Line | Trademark Corp. | FPA | Class II | |
| K911374 | Plastic Overlays | National Reading Service | HKW | Class I | |
| K911190 | Perrymeter(tm) | Perrymeter Systems | HIR | Class II | |
| K911173 | Sysmex F-310 | Toa Medical Electronics USA, Inc. | GKL | Class II | |
| K911172 | Sysmex F-610 | Toa Medical Electronics USA, Inc. | GKL | Class II | |
| K911154 | Sun Medical Smoke/fluid Evac Syst, Model Sfe-200 | Sun Medical Co., Ltd. | FYD | Class II | |
| K910957 | Masterpieces Micro System | Storz Instrument Co. | HRS | Class II | |
| K910877 | Finn Knee Prosthesis | Zimmer GmbH | KRO | Class II | |
| K910849 | Sysmex F-810 | Toa Medical Electronics USA, Inc. | GKL | Class II | |
| K910839 | Ultimate 3000 | Fonar Corp. | LNH | Class II | |
| K910304 | Rapid Coryne Syst/identif of Coryneform Bacteria | Vitek Systems, Inc. | LQL | Class I | |
| K904834 | Intavent Laryngeal Mask | Intavent Intl. S.A. | CAE | Class I | |
| K904737 | Gross Hip Femoral Component | Johnson & Johnson Orthopaedics, Inc. | JDI | Class II | |
| K904723 | Forceps | Minto Research & Development, Inc. | GEN | Class I | |
| K903175 | Advance Suture Nonabsorbable Dacron Suture | Advance Suture, Inc. | GAS | Class II | |
| K912800 | Kallestead Total Ige Microplate Kit | Bio-Rad Laboratories Inc. | DGC | Class II | |
| K912714 | Rt40 Radio Translucent | ZOLL Medical Corporation | DRX | Class II | |
| K912638 | Blood Pressure Cuffs | Vital Signs, Inc. | DXQ | Class II | |
| K912533 | Narkomed Av-E Ventilator | Draeger, Inc. | CBK | Class II | |
| K912522 | Omniview(tm) Ophthalmic Fiberendo W/needleholder | Summit Technology, Inc. | EQH | Class I | |
| K912502 | Laparoscopic Laser Fiber Diverter | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K912485 | Coltene President Jet Light/reg Body Hydrophilic | Coltene /Whaledent AG | ELW | Class II | |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase) | Serono-Baker Diagnostics, Inc. | CHP | Class I | |
| K912151 | Landers Three Strut Vitrectomy Lens Ring | Ocular Instruments, Inc. | HNH | Class I | |
| K912134 | Tbd, Lens Measuring Device | Alcon Laboratories | HRJ | Class I | |
| K912110 | Disposable o.r. Towel | American Threshold Industries, Inc. | KKX | Class II | |
| K912004 | Shepard Cryopress/camp Multi-Temp Sport Pumps | Shepherd Medical Products, Inc. | IRP | Class II | |
| K911961 | Branemark System-5.0Mm Fixture | Nobelpharma USA, Inc. | DZE | Class II | |
| K911252 | Precise Barnd Pi Disposable Surgical Staples | 3M Medical Products Group | GDW | Class II | |
| K910186 | Wyman Suture Washer | Acu Med, Inc. | HTN | Class II | |
| K910090 | Dimac Wires | Instrumentations Unltd. | DYX | Class II | |
| K905418 | Gates Glidden Drills | The Hygenic Company, LLC | DZA | Class I | |
| K912940 | Coat-a-Count Beta-2 Microglobulin Irma | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K912665 | System Bt W/remote Control Option Hearing Aid | Resound Corp. | ESD | Class I | |
| K912489 | Colorzyme Ebv Early Antigen Igg Antibody Test Sys | IMMUNO CONCEPTS, NA, Ltd. | LSE | Class I | |
| K912488 | Fluorecent Ebv-Early Antigen Igg Antibody Test Sys | IMMUNO CONCEPTS, NA, Ltd. | LSE | Class I | |
| K912473 | Accu-Placer Tm Kit | HU-Friedy Mfg. Co. LLC | EKJ | Class I | |
| K912408 | Merifluor-Cryptosporidium/giardia | Meridian Diagnostics, Inc. | MHI | Class II | |
| K912395 | Howmedica Precis Osteolock Fem Comp W/hydro Coat | Howmedica Corp. | MEH | Class II | |
| K912316 | Quikpac-II One Step Pregnancy Home Test | Syntron Bioresearch, Inc. | LCX | Class II | |
| K912256 | Precise(r) Beta Quartz Glass-Ceramic Insert | Lee Pharmaceuticals | KLE | Class II | |
| K912208 | Fresenius Safe-Connect Capd Manual Assist Device | Fresenius USA, Inc. | KDJ | Class II | |
| K912174 | Salter Labs Disposable Nipple and Nut | Salter Labs | CAN | Class I | |
| K912061 | Heparin Adsorbent | Sigma Diagnostics, Inc. | JPA | Class II | |
| K911897 | Gasparaitis Esophagram Catheter Set | E-Z-EM, Inc | KNT | Class II | |
| K911740 | Salter Labs Neonatal Nasal Oxygen Cannula | Salter Labs | CAT | Class I | |
| K911640 | Olympus Pk Tp(tm) System, Modification | Olympus Corp. | GMT | Class II | |
| K911417 | Icon Strep B Immunoenzymetric Assay | Hybritech, Inc. | GTZ | Class I |