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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K893458 | Fiberoptic Headlight System | Cuda Products Co. | EBA | Class I | |
| K893452 | Extra Strength Effergrip Denture Adhesive Cream | Warner-Lambert Co. | IZZ | Class II | |
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000 | Texas Medical Products, Inc. | FXX | Class II | |
| K893406 | Deseret Prn Adapter | Deseret Medical, Inc. | KGZ | Class I | |
| K893378 | Prothrombin Time (Pt) by Hemochron | Accriva Diagnostics, Inc. | GJS | Class II | |
| K893135 | Gent-L-Kare Ster Suct Cath Tray W/14 Fr/ster Water | Premium Plastics, Inc. | JOL | Class II | |
| K893018 | Hpi Non Sterile Exam Gloves | Tillotson Corp. | LYY | Class I | |
| K892976 | Single Use Vinyl Exam Gloves - Color Coded | Phoenix Medical Technology, Inc. | LYZ | Class I | |
| K892937 | Reusable Bowl and Spatula for Mixing Bone Cements | Dentsply Intl. | JDZ | Class I | |
| K892933 | Infralase-Laserguide Delivery System | Ximed Medical Systems | GEX | Class II | |
| K892932 | Bioprime Tm Kit | Hospal | FJK | Class II | |
| K892820 | Forceps, Surgical, Gynecological | The South India Surgical Co. Pvt., Ltd. | HCZ | Class II | |
| K892803 | Phonic Ear Ite/itc Hrng Aid 901, 902, 903, 906,911 | United Hearing Systems, Inc. | ESD | Class I | |
| K892504 | 'Exmoor' Single Use Suction Tube | Exmoor Plastics Limited | LRC | Class I | |
| K892455 | Kulzer Adhesive Cement | Kulzer GmbH | EBF | Class II | |
| K892426 | No. 86500 - Endoscopic Jet Washer | Superior Healthcare Group, Inc. | OCX | Class II | |
| K892387 | Modified Gelman Arterial Filter | Gelman Sciences, Inc. | DTM | Class II | |
| K892214 | Reverse Cutting Cannulated Cancellous Bone Screw | Ace Medical | HWC | Class II | |
| K892209 | Aptt by Hemochron(r) | Intensive Technology, Inc. | GFO | Class II | |
| K892204 | Nidek Inc. Models Yc-2000 & 3000 Ophthalmic Lasers | Nidek, Inc. | LXS | Class II | |
| K892152 | Patient Exam Gloves (Mfg. Ningbo Medical Latex) | Sinochem (USA), Inc. | LYY | Class I | |
| K892066 | Horizon Central Station | Mennen Medical, Inc. | DRT | Class II | |
| K892017 | Puraflex Patient Examination Gloves | Medsi, Inc. | LYY | Class I | |
| K891952 | Tru-Touch Vinyl Exam Gloves (Canada) | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K891855 | Winfield Latex Examination Gloves | Winfield Co., Inc. | LYY | Class I | |
| K891835 | Bud Brand Patient Examination Gloves (Vinyl) | Associated Ent., Inc. | LYZ | Class I | |
| K891418 | Latex Examination Gloves, Style 510 Lx | C & K Mfg. & Sales Co. | LYY | Class I | |
| K891403 | Hugh Young II Urological Table | Mallinckrodt Group, Inc. | IZZ | Class II | |
| K891062 | Terumo Av Fistula Needle Set | Terumo Medical Corp. | FIE | Class II | |
| K890876 | Bp-8800 Blood Pressure Monitor | Colin Medical Instruments Corp. | DRT | Class II | |
| K890292 | Pca-10, 10Cc Disp. Angiography Control Syringe | Coeur Laboratories, Inc. | DXT | Class II | |
| K885349 | Sonomicrometer, Ultrasonic Dimension System, Card. | Sonotek Corp. | DXK | Class II | |
| K885192 | Apr Collared Revision Femoral Component | Intermedics Orthopedics | JDI | Class II | |
| K885102 | Omnifit Ceramic Morse Taper Head (1002 Series) | Osteonics Corp. | LZO | Class II | |
| K885089 | Surgical Gloves | Wb Intl., Inc. | KGO | Class I | |
| K884998 | Selby Instrumentation | Advanced Spine Fixation Systems, Inc. | KWP | Class II | |
| K884800 | Acta Genos Electrocardiograph | Parexel Intl. Corp. | DPS | Class II | |
| K882818 | Seer | Marquette Electronics, Inc. | DSI | Class II | |
| K893885 | Bacton Tm, Basic Tm, Apo a-I Reagent | Catachem, Inc. | DEL | Class I | |
| K893884 | Bacton Tm, Basic Tm, Apo B Reagent | Catachem, Inc. | MSJ | Class I | |
| K893701 | Slt Contact Laser System | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K893340 | Latex Surgical Gloves | Kenmark Industrial Co., Ltd. | KGO | Class I | |
| K893255 | Spectrum, Visible Light Cure Orthodontic Adhesive | American Orthodontics | DYH | Class II | |
| K893206 | Sharplan 1075 CO2 Laser | Sharplan Lasers, Inc. | GEX | Class II | |
| K893031 | Delta (Tm) Robotic Pipettor | Siemens Healthcare Diagnostics Inc. | JQW | Class I | |
| K892915 | Pleur-Evac a-8002--Adult/pediatric Dual Collection | Deknatel, Inc. | KDQ | Class II | |
| K892687 | Cannulated Biopsy Forceps | Zinnanti Surgical Instruments, Inc. | EOQ | Class II | |
| K892506 | Patient Examination Gloves (Latex) | Universal Latex Products Co., Ltd. | LYY | Class I | |
| K892480 | Patient Examination Gloves | Foodhandler, Inc. | LYY | Class I | |
| K892309 | Patient Examination Gloves (Latex) | Min an Chemical Industrial Co., Ltd. | LYY | Class I |