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 |
|---|---|---|---|---|---|
| K993884 | Genx Microtools | <Genx> Intl., Inc. | MQJ | Class II | |
| K993881 | Genx Culture Dish | <Genx> Intl., Inc. | MQK | Class II | |
| K993390 | Remed Male Latex Condom (Super Duper) Preventor, Lucky Boy, and Summit | Remed Pharma | HIS | Class II | |
| K993037 | Lcv+ Version 2 | GE Healthcare | OWB | Class II | |
| K992699 | Nipro Blood Collection Needle | Nipro Medical Corporation | FMI | Class II | |
| K000185 | Gore-Tex Dualmesh Plus Biomaterial (1 Mm & 2Mm) | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K000170 | Secca Tubular Electrode Device, Model A4000 | Conway Stuart Medical, Inc. | GEI | Class II | |
| K994129 | Hardydisk Cefixime, 5Mcg | Hardy Diagnostics | JTN | Class II | |
| K994091 | Hardydisk Gentamicin, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K994089 | Hardydisk Chloramphenicol, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K993889 | Exeter Ceramic Femoral Heads | Howmedica Osteonics Corp | LZO | Class II | |
| K993704 | Gastro-Intestinal System En-410Wm | FUJIFILM Healthcare Americas Corporation | FDA | Class II | |
| K993436 | Cavermap Surgical Aid | Uromed Corp. | FGM | Class I | |
| K993224 | T-Gear, Model Tg/400-700 | Dontech Products B.V. | DZB | Class II | |
| K991397 | Transcutaneous Electrical Nerve Stimulator Se-30 TENS | Sein Electronics Co., Ltd. | GZJ | Class II | |
| K983928 | Kodak Home Health Monitoring System | Eastman Kodak Company | MWI | Class II | |
| K000256 | Cap Porp, Cap Torp | Gyrus Ent LLC | ETB | Class II | |
| K000225 | Card Guard Personal Electrocardiogram Transmitter, Model Cg-6206/6306 | Card Guard Scientific Survival, Ltd. | DXH | Class II | |
| K000184 | Audioscreener Oae | Kedly, Inc. | EWO | Class II | |
| K000144 | Nipro Insulin Syringe | Nipro Medical Corporation | FMF | Class II | |
| K994435 | Opc 3G All-Ceramic System, Core and Overlay Porcelains | Jeneric/Pentron, Inc. | EIH | Class II | |
| K994343 | Bact/alert Sv | bioMerieux, Inc. | MDB | Class I | |
| K994300 | Nasogastric Tube Holder, Model 160 | Dale Medical Products, Inc. | KNT | Class II | |
| K994218 | Easy Care and Tubing Sets | Medionics International, Inc. | FKX | Class II | |
| K994196 | Horizon Medical Products Microport 2 Peripheral Access Port System | Boston Scientific Corporation | LJT | Class II | |
| K993978 | Pr3 Ultrasound System | Carolina Medical, Inc. | IYO | Class II | |
| K993918 | Health-Plus, Sanitex, Reliance, Powder-Free Multi-Ply Latex Examination Glove (Natural Rubber Latex-Nitrile-Construction | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K993893 | Medx Intecam Interface | Medx, Inc. | KPS | Class II | |
| K993885 | Ultrablator Electrode | Linvatec Corporation | JOS | Class II | |
| K993861 | Fuji Computed Radiography Dual Side Reading, Both Side Reading, Fcr 5501D Dual Side Reader | FUJIFILM Healthcare Americas Corporation | MQB | Class II | |
| K993554 | Yeastest | Diagnostic Markers, Inc. | JXB | Class I | |
| K993291 | Copalis Rubella Igm | Diasorin Inc. | LFX | Class II | |
| K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis) | Surgical Instrument Systems (Sis), Ltd. | HNO | Class I | |
| K993184 | R1000 Series Insulin Pump | Animas Corp. | LZG | Class II | |
| K992689 | Mu Plus | Rad Therapy Solutions, Inc. | IYE | Class II | |
| K992571 | I-Stat System | I-Stat Corp. | JBP | Class II | |
| K992467 | Imagclear Mammography Review System | dba Systems, Inc. | LMA | Class II | |
| K992176 | Excel Ultra-Hi Formula Heat-Cured Denture Base Material | St. George Technology, Inc. | EBI | Class II | |
| K992039 | Exel i.v. Blood Line Set | Exelint Intl. Co. | FJK | Class II | |
| K000331 | Synchron Lx Systems Microalbumin Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K000274 | Eopa Elongated One-Piece Arterial Cannula with Guidewire | Medtronic Cardiac Surgical Products | DWF | Class II | |
| K000186 | Datex-Ohmeda Inovent Delivery System | GE Healthcare | MRN | Class II | |
| K000101 | Rx Viatrac 14 Peripheral Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K000090 | Guthrie Prime Powder-Free Chlorinated Patient Examination Gloves | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K000052 | X-Ray Monoblock, Monoblock Xrs-60-330 | Dynarad Corp. | ITY | Class I | |
| K000017 | Parset Secondary Administration Set, Luerlock, Model A14001e, Parset Secondary Secondary Administration Set, Model A1400 | Rd Medical Mfg., Inc. | FPA | Class II | |
| K994162 | Powered Dental Powdered Examination Gloves, with Protein Content Labeling Claim (75 Micrograms or Less) | Medtronic, Inc. | LYY | Class I | |
| K994001 | Polyglycolic Acid | Trading Consultants and Distributors Intl., Inc. | GAM | Class II | |
| K993912 | Ambiderm Powder Free Latex Examination Gloves (Violet, Blue, Green and Pink), with Protein Content Labeling Claim (50 Mi | Latexx Partners, Inc. | LYY | Class I | |
| K993832 | Autodose Infusion System, Model Ad4120, Be4210, S12050,100,200, Ff0005, 10 | Tandem Medical, Inc. | MEB | Class II |