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 |
|---|---|---|---|---|---|
| K972129 | Chlamydiatrol Ag | Blackhawk Biosystems, Inc. | MJZ | Class I | |
| K972108 | Alta Intramedullary Rod System | Howmedica Corp. | HSB | Class II | |
| K972086 | Alexander Manufacturing Co. Rechargeable Battery Part Number Ms311 | Alexander Mfg. Co. | BZK | Class II | |
| K972048 | Accurun 117 Hbeag Positive Control | Boston Biomedica, Inc. | JJY | Class I | |
| K972032 | Visualine II Methamphetimine | Sun Biomedical Laboratories, Inc. | DKZ | Class II | |
| K971982 | Karl Storz Model 203020 20 Equimat | Karl Storz Endoscopy-America, Inc. | LJH | Class II | |
| K971977 | Ksea 15.5 Fr. Flexible Choledocho-Fiberscope | Karl Storz Endoscopy-America, Inc. | FBN | Class II | |
| K971918 | Amerigel Ointment Saturated Wound Dressing | Amerx Health Care Corp. | MGQ | Unclassified | |
| K971881 | Comeg Resectoscope and Laser-Resectoscope Working Elements/urethrotomes/electrodes/albarrab Deflectors | Comeg Endoscopy | FJL | Class II | |
| K971850 | Smith & Nephew Images Endoscopes and Accessories | Smith & Nephew, Inc. | GCJ | Class II | |
| K971828 | Alexander Manufacturing Co. Rechargeable Battery Part Number Gl0810-0115 | Alexander Mfg. Co. | DQA | Class II | |
| K971827 | Alexander Manufacturing Co. Rechargeable Battery Part Number Ms71764 | Alexander Mfg. Co. | DQA | Class II | |
| K971796 | Laparotomy Bladder Neck Suspension Kit with Bone Anchors | Louisville Laboratories, Inc. | EZL | Class II | |
| K971657 | Accurun 121 Hav Igm Positive Control | Boston Biomedica, Inc. | JJY | Class I | |
| K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf) | Abbott Medical | GKZ | Class II | |
| K971021 | Chase Phrenic Nerve Pad | Chase Medical, Inc. | DWF | Class II | |
| K970660 | Dermagran Wound Management System | Derma Sciences, Inc. | KMF | Class I | |
| K970511 | Dyonics Disposable Endoscopic Surgery Blades | Smith & Nephew, Inc. | HRX | Class II | |
| K963520 | Imz Twin Plus Screw | Imz, GmbH | DZE | Class II | |
| K942685 | ECG Review Station | Mortara Instrument, Inc. | DXJ | Class II | |
| K972504 | Mvm 3.3 Mm Microendoscope | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K972420 | Lorenz Pectus Support Bar | Biomet Microfixation | HRS | Class II | |
| K972327 | Metagen Activelock Cerclage System | Pacific Materials and Interfaces | JDQ | Class II | |
| K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | JEY | Class II | |
| K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | JEY | Class II | |
| K971962 | Osteo Kirschner Wires | Osteonics Corp. | HTY | Class II | |
| K971305 | Femrx Focused Monopolar (Fmp) Opera Star System | Gynecare Innovation Center | HIH | Class II | |
| K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe) | Biosearch Medical Products, Inc. | HIR | Class II | |
| K965066 | Arrhythmia Mapping System (8100/8300) | Cardiac Pathways Corp. | DRF | Class II | |
| K964444 | Quicklock Orthopaedic Targeting System | Rdh Medical | HSB | Class II | |
| K964431 | Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) | Zimmer GmbH | LZO | Class II | |
| K964219 | Zip Condom Catheter | Goulter Medical, Inc. | EYZ | Class I | |
| K963481 | Anodyne Cc | Heyer America, Inc. | BSZ | Class II | |
| K972758 | Bactec Myco/f-Sputa Culture Vials | Becton Dickinson Microbiology Systems | MDB | Class I | |
| K972618 | Quickscreen One Step Cocaine Screening Test (9070) | Phamatech Inc. | DMN | Class II | |
| K972454 | Oxycor (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb Incorporated | LPL | Class II | |
| K972405 | Quikpac II One Step Opiate Test | Drial Consultants, Inc. | DJG | Class II | |
| K972337 | Dclare Immunodip Stickfor Microalbuminuria | Sekisui Diagnostics P.E.I. Inc. | JIR | Class I | |
| K972053 | Pixi Young Adult Referenc Population for Os Calcis and Forearm | Lunar Corp. | KGI | Class II | |
| K971878 | Vantage 2.1 Exspect | Philips North America LLC | KPS | Class II | |
| K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | CGA | Class II | |
| K971737 | Cynosure Photogenica Lpir Dermatological Laser | Cynosure, LLC | GEX | Class II | |
| K971183 | Gold Fingers | Alliance Rubber Products Sdn. Bhd. | LYY | Class I | |
| K970695 | Acs:180 Br (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29) | Chiron Diagnostics Corp. | MOI | Class II | |
| K970027 | Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery Vascular Clamp-Mobile Adj Belt 6005 | Rmds, Inc. | DXC | Class II | |
| K964831 | Surescan | Clinicon Corp. | GEX | Class II | |
| K964571 | Vision Cardioplegia Delivery System | Lifestream Int'L, Inc. | DTR | Class II | |
| K964424 | Rotavirus Eia | Trinity Biotech, PLC | LIQ | Class I | |
| K963925 | Thrombolytic Brush Catheter | Medtronic, Inc. | MCW | Class II | |
| K962271 | Electrosurgical Elecrtrodes | Northgate Technologies Inc. | HIH | Class II |