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 |
|---|---|---|---|---|---|
| K872718 | Series D Flowmeter | Medtronic, Inc. | CAX | Class I | |
| K872532 | Auto Suture Stainless Steel Sutures* | United States Surgical, A Division of Tyco Healthc | GAO | Class II | |
| K872481 | Laurier Night Safe Extra Protection Sanitary Nap. | Kao Corp. | HHD | Class I | |
| K872376 | Lipid Control Serum | Biological Industries | JJY | Class I | |
| K872287 | Lady Free Unscented Menstrual Pad | American Tissue Corp. | HHD | Class I | |
| K872023 | Amylase Test Kit | Ciba Corning Diagnostics Corp. | JFJ | Class II | |
| K871947 | Modified Huckstep Intramedullary Nail | Downs Surgical, Ltd. | HSB | Class II | |
| K871683 | Colpostar V-6 | CooperSurgical, Inc. | HEX | Class II | |
| K871681 | Photostar V-8 | CooperSurgical, Inc. | HEX | Class II | |
| K871470 | Bestcon/lubricated Condoms | Europharmaceutical Corp. | HIS | Class II | |
| K871332 | Clearplan | Unipath, Ltd. | CEP | Class I | |
| K871290 | Centricell(tm) | Polysciences, Inc. | JJH | Class I | |
| K870272 | Model 6110C Otophor | Life-Tech Intl., Inc. | ETN | Class II | |
| K872940 | Folding Wheelchair | Health Care Innovations, Inc. | IOR | Class I | |
| K872809 | Gauze Cherry Sponge | American Silk Sutures, Inc. | GDY | Class I | |
| K872808 | Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8 | American Silk Sutures, Inc. | EFQ | Unclassified | |
| K872807 | Non-Woven Tracheotomy Sponge | American Silk Sutures, Inc. | GDY | Class I | |
| K872806 | Stick Sponge, Strung Tonsil Sponge Double Strung | American Silk Sutures, Inc. | EFQ | Unclassified | |
| K872797 | Non-Skid Shoe Covers | Abco Dealers, Inc. | FXP | Class I | |
| K872787 | Modified Curlcath | Quinton, Inc. | GBQ | Class I | |
| K872735 | Howmedica Kinematic III Stabilizer Total Knee Sys. | Howmedica Corp. | HSX | Class II | |
| K872657 | Ultrapac II Sx Plus (Tm) | Medical Devices Inc. | GZJ | Class II | |
| K872648 | Solar Gold Uva Sun Tanning Bed | An-Mar International, Ltd. | FTC | Class II | |
| K872634 | Cutter Pureflo Plus IV Filter | Miles Laboratories, Inc. | FPB | Class II | |
| K872594 | Andover Moleskin | Andover Coated Products, Inc. | KGX | Class I | |
| K872593 | Andover Adhesive Tape, Surgical | Andover Coated Products, Inc. | KGX | Class I | |
| K872591 | Hard Contact Lens Remover. Item #289 | FGX International Inc. | KYE | Class I | |
| K872495 | Biocomp 2001 Biofeedback Device | Biofeedback Research Institute, Inc. | HCC | Class II | |
| K872149 | Surecath-Itp Percutaneous Access Kit | Titan Medical, Inc. | LJT | Class II | |
| K872067 | Stericap Assembly and Replacement Tray | Stericap Systems | FMG | Class II | |
| K872066 | Stericap Stopcock | Stericap Systems | FMG | Class II | |
| K872040 | Phoresor II (Tm), Model Pm700 | Motion Control, Inc. | EGJ | Class II | |
| K872031 | Uni-Fiber Non-Repairable Fiber Delivery System | Laser Media | LNK | Class II | |
| K871889 | Compression Legging Device | A-T Surgical Mfg. Co., Inc. | LLK | Class II | |
| K871338 | Novametrix Model 200 Magstim | Novametrix Medical Systems, Inc. | GWF | Class II | |
| K871082 | Fetal Care Monitor Antepartum 1500 | Pie Data Medical BV | HGM | Class II | |
| K870950 | Uniport Model Sd-60, Sd-70 | Healthcare Technologies, Inc. | LJT | Class II | |
| K870568 | Bio-Prompt(tm) | Physical Health Devices, Inc. | HCC | Class II | |
| K872907 | Dentin Adhesive | Dentsply Intl. | EBF | Class II | |
| K872890 | Synergy | Scientific Pharmaceuticals, Inc. | EBF | Class II | |
| K872598 | Micromi-Ck(tm) | Intl. Immunoassay Laboratories, Inc. | JHT | Class II | |
| K872552 | Hearing-Aid | Audio-Technica U.S., Inc. | ESD | Class I | |
| K872519 | Sterilized Omni Gel | Echo Ultrasound | JOT | Class II | |
| K872470 | Devo/mc44 Oxygen Concentrator | The Devilbiss Co. | CAW | Class II | |
| K872283 | Oral Suction Catheter | Ballard Medical Products | BSY | Class I | |
| K872154 | Modified Info Inserts for Pruitt Irri.-Occlu. Cath | Ideas for Medicine, Inc. | DQT | Class II | |
| K872153 | Stom-Vent | Gibeck Respiration | BYD | Class I | |
| K871844 | Argyle Vascular Bypass Set | Sherwood Medical Co. | DWF | Class II | |
| K871816 | Strykerscope Tm/orthoscope Tm/stryker Miniscope Tm | Stryker Corp. | EAY | Class I | |
| K871776 | Whiteside Ortholoc II Rev Post Stab Total Knee Sy | Dow Corning Wright | JWH | Class II |