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 |
|---|---|---|---|---|---|
| K933788 | Anti-Cardiolipin Antibody (Igm-Aca) Test | Immco Diagnostics, Inc. | MID | Class II | |
| K933786 | Anti-Cardiolipin Antibody (Igg-Aca) Test | Immco Diagnostics, Inc. | MID | Class II | |
| K933784 | Anti-Cardiolipin Antibody (Iga-Aca)test) | Immco Diagnostics, Inc. | MID | Class II | |
| K950810 | Rutner Biopsy Device | Cook Incorporated | FCG | Class II | |
| K950786 | Olympus Biopsy Forceps Model Fb-44 | OLYMPUS Corporation of the Americas | EOQ | Class II | |
| K950748 | Chakoff Endoscopy (Fiber Optic Light Source Routine) | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950747 | Chakoff Endoscopy (Light Source Endoscopic Xenon Arc.) | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950746 | Chakoff Endoscopy (Set Laparoscopy) | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950745 | Chakoff Endoscopy (Endoscope And/or Accessories) | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950744 | Chakoff Endoscopy (Ridgid Endoscope) | Stephen Chakoff, Inc. | GCJ | Class II | |
| K950689 | Ucb | Cox Medical Ent., Inc. | MNL | Class I | |
| K950633 | Candela Urethral/bladder Sound | Candela Corporation | FBX | Class I | |
| K950507 | Nezhat-Dorsey Laparoscopic Hand Instruments | American Hydro-Surgical Instruments, Inc. | GEI | Class II | |
| K950103 | Laparoscope, Hand Instruments | OLYMPUS Corporation of the Americas | GCJ | Class II | |
| K950027 | Cable-Ease Plate and Cable System - Trochanteric Hook | Intermedics Orthopedics | JDQ | Class II | |
| K950015 | Human Protein C Rid Test Kit | Jay H. Geller | GGP | Class II | |
| K946360 | Modular Biopsy Forcep | Cox Medical Ent., Inc. | FCL | Class I | |
| K946296 | Quadra-Coil Ureteral Stent | Surgitek | FAD | Class II | |
| K946089 | Nezhat-Dorsey(tm) Reusable Aspiration-Vac(tm) Probes with and without Puncture Cannula | American Hydro-Surgical Instruments, Inc. | GCJ | Class II | |
| K945868 | R&d Part Nos. 5262, 5543, 5432, 5469 | R & D Batteries, Inc. | FCO | Class I | |
| K945613 | Duracon(tm) Unicompartmental Femoral Component | Howmedica Corp. | HSX | Class II | |
| K945575 | Pro Barrier(tm) Tube Sox(tm) | Cottrell, Ltd. | MMN | ||
| K945209 | Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments | Karl Storz Endoscopy-America, Inc. | GCF | Class II | |
| K945203 | Mitek Thraded Anchor (Mta) | Mitek Surgical Products, Inc. | JDR | Class II | |
| K945081 | Transtympanic Endoscope | Endooptiks, Inc. | EOB | Class II | |
| K944521 | Rechargeable Batteries | R & D Batteries, Inc. | FCO | Class I | |
| K944192 | Anti-Nuclear Antibody (Ana) Test Kit W/rat Liver | Light Diagnostics | DBL | Class II | |
| K944191 | Anti-Nuclear Antibody(ana) Test Kit W/mouse Liver | Light Diagnostics | DBL | Class II | |
| K943967 | Onyx | Coulter Corp. | GKZ | Class II | |
| K943957 | Restoration Ha Acetabular Cup Series | Osteonics Corp. | MEH | Class II | |
| K943937 | Manual Instruments | Pantheon Surgical Products | HRX | Class II | |
| K943774 | Osteonics Restoration Monolithic Hip Stem | Osteonics Corp. | LZO | Class II | |
| K943768 | Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire Ant | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K943638 | Usdl Model Select 1000 Frequency Doubled Nd:yag Laser System | United States Dental Laser, Inc. | GEX | Class II | |
| K943630 | Diastat Anti-Mpo (Panca) Kit | Shield Diagnostics, Ltd. | MOB | Class II | |
| K942813 | Diastat Anti-Pr3 (C-Anca) Kit | Shield Diagnostics, Ltd. | MOB | Class II | |
| K941692 | Female Length All Silicone Urological Catheter | Rochester Medical Corp. | EZL | Class II | |
| K941534 | Modular Vs-22 Cemented Femoral Hip System | 3M Company | KWY | Class II | |
| K941507 | Themo-Flo System 3 Laparoscopic/hysteroscopic System | Sanese Medical Corp. | HET | Class II | |
| K941309 | Newport Electronic Manometer | Newport Medical Instruments, Inc. | CBK | Class II | |
| K932387 | Conceptus Vari-Soft Cath/pirouette Posit Mandrel | Conceptus, Inc. | HET | Class II | |
| K930503 | Clirans Wet Pack Hollow Fiber Dialyzer | Terumo Medical Corp. | FJI | Class II | |
| K950297 | Argus Endoscopic Plastic Surgery Instrument System | Argus Medical Co., Inc. | GCJ | Class II | |
| K950177 | Ck Qvet | Prisma Systems | CGS | Class II | |
| K950094 | Scimed 6 French Micro-Max(tm) Guide Catheter | Scimed Life Systems, Inc. | DQY | Class II | |
| K950076 | Laparoscope | OLYMPUS Corporation of the Americas | GCJ | Class II | |
| K946052 | Powerflex(tm) 5F Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K945953 | Gore Laparoscopic Suture Passer (Non-Sterile) | W. L. Gore & Associates, Inc. | GCJ | Class II | |
| K945931 | Rmi Cirkuit-Guard(tm) Pressure Relief Valve | Research Industries Corp. | DTL | Class II | |
| K945922 | Non-Prescription Sunglasses | Csi Industries, Inc. | HQY | Class I |