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 |
|---|---|---|---|---|---|
| K911483 | Laparoscopic Trocar | United States Endoscopy Group, Inc. | DRC | Class II | |
| K911476 | Laparoscopic Electrode with Lavage and Suction | United States Endoscopy Group, Inc. | GEI | Class II | |
| K911475 | Laparoscopic Vessel Articulator | United States Endoscopy Group, Inc. | DWP | Class II | |
| K911272 | Endoscopic Needlholder Cat. Number 114705 | Edward Weck, Inc. | FHG | Class II | |
| K910074 | Laparomed Hook/spatula Device | Laparomed Corp. | GEI | Class II | |
| K912559 | Nova 1 Sodium/potassium/hematocrit Analyzer | Nova Biomedical Corporation | JGS | Class II | |
| K912535 | Imx Total B-Hcg | Abbott Medical | JHI | Class II | |
| K912534 | Imx Hcg | Abbott Medical | JHI | Class II | |
| K912519 | Amylase Reagent | Genzyme Corporation | JFJ | Class II | |
| K912413 | Chem-Link Data Base Manager | Technicon Instruments Corp. | JJQ | Class I | |
| K912387 | I-Stat Model 100 Port Clin Analyzer & Test Pack | I-Stat Corp. | JGS | Class II | |
| K912373 | Keto-340 II | Ihara Medics U.S., Inc. | JIN | Class I | |
| K912217 | Kodak Ektachem Clinical Chemistry Slides | Eastman Kodak Company | DIH | Class I | |
| K911940 | Opus(r) Tobramycin | Pb Diagnostic Systems, Inc. | LCR | Class II | |
| K911801 | Ketosite(tm)/stat-Site(tm)/ketosite(tm) Low-Hi Con | Gds Technology, LLC | JIN | Class I | |
| K911771 | Ard(tm) Antimicrobial Removal Device | BD Becton Dickinson Vacutainer Systems Preanalytic | LJK | Class II | |
| K911700 | Monopolar Pollypectomy Snare | Everest Medical Corp. | KNS | Class II | |
| K911585 | Omnifit II Epf Hip Stem Series | Osteonics Corp. | MEH | Class II | |
| K911572 | Mg II Porous Cobal T-Chrome Femoral Component | Zimmer GmbH | JWH | Class II | |
| K911516 | High Profile Chin Implant | Implantech Associates Inc | FWP | Class II | |
| K911515 | Extended Malar Implant | Implantech Associates Inc | LZK | Class II | |
| K911514 | Articulated Chin Implant | Implantech Associates Inc | FWP | Class II | |
| K911513 | Trapezoidal Malar Implant | Implantech Associates Inc | LZK | Class II | |
| K911436 | Sharps Pin Cushion(tm) Container | Catalyst, Inc. | FMI | Class II | |
| K910657 | Qualtex Island Dressing | DeRoyal Industries, Inc. | KGX | Class I | |
| K910093 | Futura Femoral Hip Stem | O'Tec Corp. | JDI | Class II | |
| K905450 | Adult Circle Breath Circuit W/intern Gas Samp Line | Vital Signs, Inc. | CAI | Class I | |
| K904499 | Nicos (Non-Invasive Cardiac Output System) | Ackrad Laboratories | KFG | Class I | |
| K912466 | Oldelft Simulix-Mc | Oldelft Corp. of America | KPQ | Class II | |
| K912128 | Maxi-Scope or Ultra-Scope | Seiichi Mfg., Inc. | LDE | Class I | |
| K911902 | Temperlite(tm) Saw Blade | Sierra Surgical, Inc. | HSD | Class II | |
| K911806 | Magnetic Resonance Diagnostic Accessory | General Electric Co. | LNH | Class II | |
| K911773 | Philips Telescan | Philips North America LLC | LMD | Class I | |
| K911703 | Cordis 8 French 0.084 I.d. Ptca Guiding Catheter | Cordis US Corp. | DQO | Class II | |
| K911613 | Var Aural Grom Ag/s9,sd8.00.28.5/0.2 Ns/s/6823 1.4 | Exmoor Plastics Limited | LCR | Class II | |
| K911552 | Anatomic Toe System | Orthopaedic Biosystems, Ltd. | LZJ | Unclassified | |
| K911548 | Acryl-X System Tm | Sonokinetics, Inc. | JDX | Class II | |
| K911528 | Isola(tm) Spine System - Iliac Screw | Acromed Corp. | KWP | Class II | |
| K911445 | Fastlok (Staple and Buckle) Fixation System | Neoligaments, Ltd. | JDR | Class II | |
| K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | GEH | Class II | |
| K911412 | Olympus Disposable Biopsy Valve | Olympus Corp. | EOQ | Class II | |
| K911410 | Ps Medical Button Valve | Pudenz-Schulte Medical Research Corp. | JXG | Class II | |
| K911338 | Lima Cement Restrictor | Turnkey Intergration USA, Inc. | JDK | Class II | |
| K911276 | Magnetic Resonance Device Accessory | Toshiba America Mri, Inc. | LNH | Class II | |
| K911244 | Vlc Glass Ionomer Liner | Dentsply Intl. | EJK | Class II | |
| K911150 | Sorex Safe-Air | Sorex Medical | GEX | Class II | |
| K910939 | Cook Tissue Morcellator | Cook Incorporated | GEI | Class II | |
| K910618 | Suh Vent Tube | Boston Medical Products, Inc. | ETD | Class II | |
| K905594 | Neurofile Data Storage/accesories to the EEG-4300 | Nihon Kohden America Inc | GWK | Class II | |
| K905504 | Staining System for Pneumocystis Carinii | Dako Corp. | LYF | Class II |