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 |
|---|---|---|---|---|---|
| K962554 | Flexiflo Low-Profile Balloon Gastrostomy Tube | Abbott Medical | KNT | Class II | |
| K973974 | Dade Tru-Liquid Cardiac Control | Dade Intl., Inc. | JJT | Class I | |
| K973726 | Fingerprint Drug Screening Device | Applied Technology Ventures, LLC | DKZ | Class II | |
| K973667 | Vitapex Pre-Loaded Dental Syringe | Neodental Chemical Products Co., Ltd. | KIF | Class II | |
| K973578 | Invotec Ear Tampon (Wick) W/string | Invotec International, Inc. | KCN | Class I | |
| K973551 | Medi-Plus, Health-Plus, Sanitex, Reliance | Pwa Industries Sdn. Bhd. | LZA | Class I | |
| K973536 | Ace Phenobarbital Reagent/aed Calibrators | Schiapparelli Biosystems, Inc. | DLJ | Class II | |
| K973215 | Stereotactic Needle Core Biopsy System | Laurus Medical Corp. | KNW | Class II | |
| K973200 | Caries Stain | Parkell, Inc. | LFC | Class II | |
| K973134 | Omni F.t. Latex Examination Glove, Powdered | Omnigrace, Ltd. | LYY | Class I | |
| K973070 | Conveen Easicath Set | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K973007 | Datascope's 10 Fr. Flexisheath Percutaneous Introducer | Datascope Corp. | DYB | Class II | |
| K972962 | 3M Cdi Blood Parameter Monitoring System 500 | 3M Company | DRY | Class II | |
| K972927 | Endoscopes W/permanent and Removable Eyepiece, Panoview Plus Telescope W/plug-on Connector | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K972624 | Poly (Vinyl) Exam Glove, Powder-Free | Copioumed Intl., Inc. | LYZ | Class I | |
| K972203 | Babybird Ventilator, Portable Lifecare Ventilator, External Pressure Limiter, Volume Ventilator with Pressure Limit | Allied Medical LLC | CBK | Class II | |
| K971928 | Quest Vessel Catheter | Quest Medical, Inc | DWF | Class II | |
| K965022 | Monoclonal Mouse Anti-Human Cd30, Ki-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code No. Mo751) | Dako Corp. | DEH | Class II | |
| K962473 | (Vcom, Irvs, Rvs) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with | Data Critical Corp. | MSX | Class II | |
| K962359 | Lifepak 300 | Physio Control, Inc. | MKJ | Class III | |
| K973695 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K973158 | Oratec Interventions Model Orastat Monopolar Cautery Device | Oratec Interventions, Inc. | GEI | Class II | |
| K973081 | Digitizer Director: Image Compression Module (Ho4059-Rev 2.0) | Howtek, Inc. | LLZ | Class II | |
| K973079 | L7 Transducer Used on Aspen Model Ultrasound System | Acuson Corp. | ITX | Class II | |
| K973012 | Mdc Safe Step Safety Blood Collection Needle System | MDC Research, Ltd. | FMI | Class II | |
| K972464 | Vitalmix Plus Empty i.v. Container | Pacific Device, Inc. | KPE | Class II | |
| K972295 | Seraquest Vzv Igg | Quest Intl., Inc. | LFY | Class II | |
| K972090 | Powder-Free Hypoallergenic Nitrile Examination Gloves | Shen Wei (USA), Inc. | LZA | Class I | |
| K972057 | Powertrek Instruments | Medtrek Corp. | ERL | Class II | |
| K971838 | Micro Electrodes | CooperSurgical, Inc. | KNF | Class II | |
| K971295 | Ave Bridge Stent System | Arterial Vascular Engineering, Inc. | FGE | Class II | |
| K970857 | Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio | Davis & Geck, Inc. | CAC | Class II | |
| K974000 | Y-Glutamyltransferase-Sl Assay , Cataloge Number 324-10, 324-30 | Sekisui Diagnostics P.E.I. Inc. | JQB | Class I | |
| K973973 | Elecsys Callcheck Digoxin | Boehringer Mannheim Corp. | DMP | Class I | |
| K973972 | Perfect Ear/ Mini-Canal/ Pe-M, Pe-Ml, Pe-Md), Perfect Ear/ C.i.c./ (Pec, Pe-Cd) (with or without Rid-Wax Barrier) | Perfect Ear | ESD | Class I | |
| K973933 | Serum Iron-Sl Assay, Catalogue Numbers 157-10, 157-30 | Sekisui Diagnostics P.E.I. Inc. | JIY | Class I | |
| K973886 | Oticon Digisound Compact | Oticon, Inc. | ESD | Class I | |
| K973885 | Oticon Digisound Ite | Oticon, Inc. | ESD | Class I | |
| K973879 | Osom Card Hcg-Urine Test | Wyntek Diagnostics, Inc. | JHI | Class II | |
| K973665 | Magnatone / Sterling/ St; Magnatone/db; Magnatone/ Liberty/ Lb; Magnatone/ Pearl/ph C.i.c., S.p.i., One Touch, Designer | Magnatone Hearing Aid Corp. | ESD | Class I | |
| K973533 | Nidek Stereo Disc Camera(3-Dx)/nidek Stereo Fundus Camera(3-Dxf) | Nidek, Inc. | HKI | Class II | |
| K973414 | Ace Phenytoin Reagent, AED Calibrators | Schiapparelli Biosystems, Inc. | DIP | Class II | |
| K973306 | Il Test Aptt-Sp | Instrumentation Laboratory Co. | GFO | Class II | |
| K973226 | Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/s, Diabolo Tympanic Ventilation Tube, Minimal T) | Heinz Kurz GmbH Medizintechnik | ETD | Class II | |
| K973220 | Rodenstock Laser Slitlamp | G. Rodenstock Instrumente GmbH | HQF | Class II | |
| K973218 | Nidek Handy | Nidek, Inc. | HKI | Class II | |
| K973082 | Ventral Wall Defect Reduction Silo | Specialty Surgical Products, Inc. | FTL | Class II | |
| K972961 | Stelkast Bipolar System | Globus Medical, Inc. | JDI | Class II | |
| K972903 | Imatron Ultra Access Workstation with Cardiac Software Extensions | Imatron, Inc. | JAK | Class II | |
| K972696 | Il Test D-Dimer | Instrumentation Laboratory Co. | DAP | Class II |