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 |
|---|---|---|---|---|---|
| K960988 | Lactosorb Trauma Plating System | Poly-Medics,Inc. | HRS | Class II | |
| K960950 | Franco Sordelli Sunglasses | Franco Sordelli & C. SNC | HQY | Class I | |
| K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | LPL | Class II | |
| K960890 | Sunglasses or Multiple | Outdoor Action Wear Specialties | HQY | Class I | |
| K960805 | Arthoscope | United States Surgical, A Division of Tyco Healthc | HRX | Class II | |
| K960684 | Hearing Aid - Air Conduction | Resound Corp. | ESD | Class I | |
| K960680 | Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-Es, Edr-Ev, & Edr-P1 | Resound Corp. | ESD | Class I | |
| K960164 | Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140 | Bio-Interfaces, Inc. | LYC | Class II | |
| K955326 | Sports Contrast Therapy System St 7000 | Burke Neutech, Inc. | ILO | Class II | |
| K955306 | Omega+ Compression Screw System | Howmedica Corp. | KTT | Class II | |
| K955034 | Forceguard | Impact Monitors, Inc. | IRN | Class II | |
| K954614 | Eos Brand Disposable Proctoscope | North Eos Industries, Inc. | GCP | Class II | |
| K954135 | Powerchair | Wheelcare Scooters, Inc. | ITI | Class II | |
| K953495 | Eia Kit for the Detection of Gbm Antibodies | Scimedx Corp. | DBL | Class II | |
| K952595 | Haemophilus Test Medium (Htm) | Clinical Standards Laboratories, Inc. | JSO | Class II | |
| K944673 | Mri's All Silicone Foley Catheter Temperature Probe | Regulatory & Marketing Services, Inc. | EZL | Class II | |
| K960517 | Bard Tru-Trac Peripheral Balloon Dilatation Catheter | C.R. Bard Inc | LIT | Class II | |
| K960501 | Ultra-Thin Diamond Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K960483 | Steinman Pin | American Medical Specialties, Inc. | HTY | Class II | |
| K960482 | K-Wire | American Medical Specialties, Inc. | HTY | Class II | |
| K960366 | Sensititre 18 Hour Susceptibility Plates | Accumed Intl., Inc. | LTT | Class II | |
| K960264 | Conmed EKG Stripper | Conmedcorp | DRX | Class II | |
| K960143 | G.e. Sterile Digital Angiographic Tray | GE Healthcare | DWS | Class I | |
| K955944 | Osteonics N2/vac Packaging Process | Osteonics Corp. | KWS | Class II | |
| K955135 | 0.014 Intermediate Guide Wire W/phosphorylcholine Polymer Coating | Biocompatibles, Ltd. | DQX | Class II | |
| K955020 | Penevac Abc Handpiece | I.C. Medical, Inc. | GEI | Class II | |
| K954687 | Access Rubella Igg | Bio-Rad Laboratories Inc. | LFX | Class II | |
| K942247 | Small Bowel Analysis Software | Diversatek Healthcare Inc | FFX | Class II | |
| K940663 | Peacock Plan | Nomos Corp. | IYE | Class II | |
| K960330 | Instatrak | Visualization Technology, Inc. | LLZ | Class II | |
| K960035 | Carbon Dioxide - Dst | Trace America, Inc. | KHS | Class II | |
| K955767 | Cofied Modular Shoulder System | Smith & Nephew Richards, Inc. | KWS | Class II | |
| K955327 | Hp Sonos 100Cf Ultrasound Imaging System | Hewlett-Packard Co. | IYN | Class II | |
| K955060 | Accelerated Transmission Protocol | Instromedix, Inc. | DXH | Class II | |
| K954906 | First Picc Introducer Catheter | Becton Dickinson Vascular Access, Inc. | DYB | Class II | |
| K953530 | Diagnostic Ultrasound Tranducers P10a, P12a, Pt10a, Pa11-a | Biosound, Inc. | IYO | Class II | |
| K951942 | Last Image Hold | Insight Systems | LMB | Class I | |
| K951581 | Pinnacle3 Apex | Philips North America LLC | IYE | Class II | |
| K960809 | Philips Site View Workstation | Philips North America LLC | LMD | Class I | |
| K955144 | Radiotherapeutics RF Generator Model RF-1000 | Radiotherapeutics Corp. | GEI | Class II | |
| K961188 | Cefepime, 30 Mcg, Sensi-Disc | BD Becton Dickinson Vacutainer Systems Preanalytic | JTN | Class II | |
| K961175 | Trogard Trocar Dialating Trocar System | Conmedcorp | GCJ | Class II | |
| K961109 | Active Lh Irma | Diagnostic Systems Laboratories, Inc. | CEP | Class I | |
| K960866 | Lrm Produces Guidewires on an Oem Basis for Manufacturers,kit Assemblers, and Distributors. | Lake Region Mfg., Inc. | KNY | Class II | |
| K960804 | Miracle Ear & Audiotone Model Ite/itc/cic | Miracle-Ear, Inc. | ESD | Class I | |
| K960748 | Modified Hand Instrument Devices | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K960476 | Ethicon Bipolar Scissors and Accessory Cable | Ethicon, Inc | GEI | Class II | |
| K960065 | Temno Double Shot Biopsy Needle | Bauer Medical, Inc. | KNW | Class II | |
| K960064 | Temno Achieve Biopsy Needle | Bauer Medical, Inc. | KNW | Class II | |
| K955825 | Smith S-100 Time & Temperature Control | Smith Companies Dental Products | EGY | Class II |