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 |
|---|---|---|---|---|---|
| K920373 | Maestro Digital Video System | International Imaging Electronics | IYO | Class II | |
| K915890 | Autoclavable Thera-Mist Humidifier P3600, Modified | Pegasus Research Corp. | BTT | Class II | |
| K915773 | P-300 Capnograph and Pulse Oximeter | Pryon Corp. | DQA | Class II | |
| K915735 | Flexiflo Quantum ENT. Pump Sets and ENT. Nut. Cont | Abbott Medical | KNT | Class II | |
| K915679 | Excel Duopaulse Model 2000 | Excel Tech., Ltd. | GEX | Class II | |
| K914459 | Automatic Tubing Clamp | Rocky Mountain Research, Inc. | FIG | Class II | |
| K922077 | Modified Site Power Handpiece | Chiron Vision Corp. | EKX | Class I | |
| K922040 | Neoplastine Ci Plus | American Bioproducts Co. | GJS | Class II | |
| K921795 | Bacton(tm), Auto-Apo a-1 Reagent | Bacton Assay Systems, Inc. | MSJ | Class I | |
| K921438 | Disposable Latex Examination Gloves | Perlink USA, Inc. | LYY | Class I | |
| K920471 | Levy Articulating Retractor | Lifeguard Medical Products, Inc. | GAD | Class I | |
| K914416 | Breath-Easy, Modification | Icor AB | HME | Class I | |
| K912183 | Type 9050/Neo | S & W Medico Teknik | DPS | Class II | |
| K921862 | Bacton(tm), Auto-Apo B Reagent | Bacton Assay Systems, Inc. | MSJ | Class I | |
| K921562 | Jobst Extremity Pump System 7500 | Jobst Institute, Inc. | JOW | Class II | |
| K921479 | Duceratin/duceram Lfc Dental Porcelain | Degussa AG | EIH | Class II | |
| K921316 | Mg-1001 Tube Housing Assembly | Magma Corp. | ITY | Class I | |
| K921246 | Imz Surgical Instrument Tray | Interpore Intl. | DZE | Class II | |
| K920412 | Modified Ortho Ebv Vca-Igg Elisa | Ortho Diagnostic Systems, Inc. | MCD | Class I | |
| K920254 | Coils for Rx4000 & Rx5000 MRI Systems | Resonex, Inc. | LNH | Class II | |
| K915740 | Disposable o.r. Towel, Sterile | American Threshold Industries, Inc. | KKX | Class II | |
| K913644 | Vita in-Ceram | Vident | EIH | Class II | |
| K913324 | Mityvac(r) Saftisoft Obstetrical Vacuum Deliv Kit | Neward Enterprises, Inc. | HDB | Class II | |
| K922712 | Spur Infant/child with Open Reservoir System | Ambu, Inc. | BTM | Class II | |
| K922707 | Spur Adult with Open Reservoir System | Ambu, Inc. | BTM | Class II | |
| K922606 | Multi Joint Weight System Model #940-100 | Biodan Medical Systems, Ltd. | ISD | Class II | |
| K922603 | Total Work Integrator, Model #940-110 | Biodan Medical Systems, Ltd. | ISD | Class II | |
| K922602 | Cable Column Weight System Model #940-200 | Biodan Medical Systems, Ltd. | ISD | Class II | |
| K922305 | Coyote Electric Scooter-3Wheeled | Mobility Mfg. Co. | INI | Class II | |
| K922304 | Roadrunner Electric Scooter-3 Wheeled | Mobility Mfg. Co. | INI | Class II | |
| K922253 | Keratoref L60 | Luneau Ophtalmologie SA | HLQ | Class I | |
| K922160 | Aquamotion by Ferno Ille Hydrotherapy Pools | Aquamotion, Inc. | ILJ | Class II | |
| K922010 | Prospect(tm) Giardia Microtiter Assay/modification | Alexon, Inc. | MHI | Class II | |
| K921583 | Dryslide(tm), Pyr | Difco Laboratories, Inc. | JTO | Class I | |
| K921418 | Ultra-Core Biopsy Needles | Medical Device Technologies, Inc. | DWO | Class I | |
| K921183 | Diastat Anti-Mitochondrial Antibody Kit | Shield Diagnostics, Ltd. | DBM | Class II | |
| K920974 | Bactidrop Acridine Orange | Remel Inc | JFO | Class II | |
| K920973 | Bactidrop Indole (Erlich's) | Remel Inc | JTO | Class I | |
| K920927 | Kemtrol Serum Control-Normal Cat No. 7024 | Helena Laboratories, Corp. | JJY | Class I | |
| K920829 | Cobas Core Ferritin Eia | Roche Diagnostic Systems, Inc. | JMG | Class II | |
| K920761 | Urine Cultur Stabilization Transport Tube | Bio Medicus, Inc. | LIO | Class I | |
| K920667 | Great Toe Implant | Acu Med, Inc. | LZJ | Unclassified | |
| K920608 | America System | I. Klimov Co. | KTT | Class II | |
| K914848 | Cd4 Monoclonal Antibodies | Gen Trak, Inc. | GKZ | Class II | |
| K914847 | Cd8 Monoclonal Antibodies | Gen Trak, Inc. | LIZ | Class II | |
| K914846 | Cd2 Monoclonal Antibodies | Gen Trak, Inc. | GKZ | Class II | |
| K914306 | Tsrh(tm) Lateral Offset Plate | Sofamor Danek Mfg., Inc. | KWP | Class II | |
| K921816 | Vitek Immun Assay Sys(vidas) Thyroi Stim Hor Assay | Biomerieux Vitek, Inc. | JLW | Class II | |
| K921807 | Ultraline Sterile Disposable Fiber | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K921671 | Surgilase Fiberlase Vco2 Laser Waveguide | Surgical Products Corp. | GEX | Class II |