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 |
|---|---|---|---|---|---|
| K873382 | Platelet Extract Reagent | Bio/Data Corp. | GGW | Class II | |
| K872983 | Toray Anthron Angiographic Catheters | Toray Industries (America), Inc. | DQR | Class II | |
| K872959 | Clearfil Photo Bond | Kuraray Co. | KLE | Class II | |
| K872904 | Binax Equate Strep B | Binax, Inc. | GTZ | Class I | |
| K872504 | Lubricated Condom | Royal American Industries, Inc. | HIS | Class II | |
| K873330 | Ktp/532 Laser | Laserscope | LNK | Class II | |
| K874360 | Plastic Tubing Connector | American Medical Technology, Inc. | FPK | Class II | |
| K874317 | Poirier Kid-Roller Manual Wheelchair | Roseburg SA | IOR | Class I | |
| K873679 | Select Shoulder System | Intermedics Orthopedics | HSD | Class II | |
| K873669 | Comfeel Ulcus Ulcer Care System | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K873645 | Stainless 22-13-5 Suture Wire | Zimmer GmbH | GAQ | Class II | |
| K873364 | Hypertherm Technologies' Heat Compress | Hypertherm Technologies, Inc. | IMD | Class I | |
| K873081 | Edentec Multi-Channel Recorder | Edentec Corp. | DQA | Class II | |
| K873010 | Surface Temperature Scanner | Omega Medical Corp. | FLL | Class II | |
| K872448 | Blood Containment Pack | Professional Medical Services | LRO | Class II | |
| K872036 | Rich-Mar Conductive Gel | Rich-Mar Corp. | IPF | Class II | |
| K872006 | Disposable Barium Enema Tip with Retention Cuff | Mac Lee Medical Products | FGD | Class II | |
| K874324 | Model a-17, Behind-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K874114 | Trauma Table II | Xre Corp. | IXR | Class II | |
| K874113 | Omni Diagnost | Xre Corp. | IXR | Class II | |
| K873683 | Code #23 R System (Dentin Adhesive Material) | Pentron Corp. | EBF | Class II | |
| K873661 | Chrome-Cobalt Base Dental Alloy | North American Alloys, Inc. | EJH | Class II | |
| K873618 | Stereotix | Thomson-Cgr Medical Corp. | IZH | Class II | |
| K873284 | Oxygen/sterile Air Gen Syst/surgical Handpieces | Litton Systems, Inc. | CAW | Class II | |
| K872931 | Teca/medelec Ttt Thermal Threshold Tester | Teca, Inc. | LLN | Class I | |
| K872860 | Insufflator Tubing | MEDLINE INDUSTRIES, LP - Northfield | HIG | Class II | |
| K872057 | Fetal Scalp Electrode | Medical Accessories, Inc. | HGP | Class II | |
| K871579 | Model 2100 Nd:yag Surgical Laser Gynecological Use | Sharplan Lasers, Inc. | HHR | Class II | |
| K870857 | Abcom 1 Cardiac Output Monitor | Applied Biometrics, Inc. | JOP | Class II | |
| K874370 | Surgical Prep Razor | Derma-Safe Co. | LWK | Class I | |
| K874342 | Ligature Carrier/packer, Hydroxylapatite | Cox-Uphuff Intl. | GEJ | Class I | |
| K874274 | Revised Labeling for Amphetamine Test Kit | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K874273 | Revised Labeling for Amphetamine Test Kit | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K874272 | Revised Labeling for Methaqualone Test Kit | Roche Diagnostic Systems, Inc. | KXS | Class II | |
| K874271 | Revised Labeling for Cocaine/cocaine Meta. Test | Roche Diagnostic Systems, Inc. | DIO | Class II | |
| K874270 | Revised Labeling for Lsd Test Kit | Roche Diagnostic Systems, Inc. | DLB | Class II | |
| K874268 | Revised Labeling for Morphine Test Kit | Roche Diagnostic Systems, Inc. | DJG | Class II | |
| K874267 | Revised Labeling for Pcp Test Kit | Roche Diagnostic Systems, Inc. | LCM | Unclassified | |
| K874266 | Revised Labeling for Barbiturate Test Kit | Roche Diagnostic Systems, Inc. | DIS | Class II | |
| K874265 | Revised Labeling for Benzodiazepine Test Kit | Roche Diagnostic Systems, Inc. | JXM | Class II | |
| K874243 | Abdominal/vascular Retractor-Split Wishbone 163000 | Pilling Co. | GAD | Class I | |
| K874223 | Emit Tobramycin Assay | Syva Co. | KLB | Class II | |
| K874213 | Aca Du Pont Urine Cocaine Metabolite (U Coc)screen | E.I. Dupont de Nemours & Co., Inc. | DIO | Class II | |
| K874210 | Revised Labeling for Abuscreen Eia Barbiturate | Roche Diagnostic Systems, Inc. | DIS | Class II | |
| K873575 | Uniport Models Sd-90, Td-60, Td-70 & Td-90 | Healthcare Technologies, Inc. | LJT | Class II | |
| K873388 | Keeler Ctu Cryo System | Keeler Instruments, Inc. | HPS | Class II | |
| K873287 | Irrigation Tray (W/120cc of Sterile Normal Saline) | Todd Medical, Inc. | KOD | Class II | |
| K872329 | Infuse-a-Port Additional Sizes | Shiley Infusaid, Inc. | LJT | Class II | |
| K872145 | Cellsoft(tm)-Casa (Series 1000,2000 & 3000) | Cryo Corp. | GKL | Class II | |
| K872039 | Model Sk-14 Starter Kit for Dental Iontophoresis | Life-Tech Intl., Inc. | EAT | Class II |