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 |
|---|---|---|---|---|---|
| K953440 | Ellman Laptrode | North American Technical Services Corp. | GCJ | Class II | |
| K953383 | Wyntek Osom Hcg-Urine Test | Wyntek Diagnostics, Inc. | JHI | Class II | |
| K953291 | Quanta Lite Aca Screen (Hrp) | Inova Diagnostics, Inc. | MID | Class II | |
| K953103 | Lapping Tool Kit | Steri-Oss, Inc. | DZE | Class II | |
| K953034 | H/s Catheter Set(61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | LKF | Class II | |
| K953013 | Merocel Reinforced Silicone Sheets | Merocel Corp. | KHJ | Class II | |
| K952562 | Cardiometrics Accutrac Intravascular Guide Wire | Cardio Metrics, Inc. | DQX | Class II | |
| K952422 | Elastic Impression Cream | Teledyne Water Pik | ELW | Class II | |
| K952274 | Chemoguard, P2 Hirisk | Biosafety Systems, Inc. | FMI | Class II | |
| K951814 | Triumph-1 Port | Boston Scientific Corporation | LJT | Class II | |
| K951299 | Easy Pneumatic Crown and Bridge Remover | Dentco, Inc. | EIS | Class I | |
| K950416 | Bair Hugger Model 600 Unit, Blankets | Augustine Medical, Inc. | DWJ | Class II | |
| K944931 | Becton Dickinson Blunt Steel Cannula | BD Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | |
| K940537 | Kirschner(r) Modular II-C(tm) Total Shoulder System | Kirschner Medical Corp. | KWT | Class II | |
| K953816 | Dcurasol Gel Wound Dressing | DPT Laboratories, Ltd. | MGQ | Unclassified | |
| K953646 | Unitron Model Ikon Aohpl | Unitron Industries, Inc. | ESD | Class I | |
| K953631 | Snip Input Compression Class a | Midwest City Hearing Aid Center | ESD | Class I | |
| K953525 | Ultradent Flowable Composite | Ultradent Products Inc. | EBF | Class II | |
| K953501 | Adi Sterile Gauze Sponges | Asia Dynamics Inc. | EFQ | Unclassified | |
| K953243 | Lap Wash System: Reuseable Lens Washer & Irrigating Sheath | Devmed Group, Inc. | GCJ | Class II | |
| K953206 | Dhd Metered Dose Inhaler (Mdi) Spacer (Modification) | Dhd Diemolding Healthcare Div. | CAF | Class II | |
| K953174 | Microquatz Medical Linear Modulator Accessory | Microquartz Medical, Inc. | GEX | Class II | |
| K953119 | Bosworth Resin II | Bosworth Co. | EBI | Class II | |
| K953074 | Modified Luxar Lx-20 Family CO2 Laser System | Luxar Corp. | GEX | Class II | |
| K953026 | Minipiezon | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K953015 | Safeskin Supra | Safeskin Corp. | KGO | Class I | |
| K952993 | Safeskin Supra | Safeskin Corp. | KGO | Class I | |
| K952981 | Filtresse, Smoke Filtration System, 115 Vac & 230 Vac | Utah Medical Products, Inc | FYD | Class II | |
| K952974 | Quadralase (Microquartz Medical Adjustable Side-Firing Laser Fiber) | Microquartz Medical, Inc. | GEX | Class II | |
| K952916 | Shiatsu Master Massager Cushion | Kinsei Shiatsu, Inc. | IRO | Class I | |
| K952792 | Padless Electrosurgical Pencil | Lca, Inc. | GEI | Class II | |
| K952709 | Prothesis, Chin, Internal | Spirit Ridge Technologies | FZE | Class II | |
| K952708 | Pectoralis Implant | Spirit Ridge Technologies | FZE | Class II | |
| K952707 | Silicone Elastomer Malar Implant | Spirit Ridge Technologies | FZE | Class II | |
| K952706 | Spirit Ridge Silicone Carving Block | Spirit Ridge Technologies | FZE | Class II | |
| K952705 | Spirit Ridge Nasal Implant | Spirit Ridge Technologies | FZE | Class II | |
| K952662 | Comp=flow | Jeneric/Pentron, Inc. | EBF | Class II | |
| K952619 | Bio-Oss Ceramic | Geistlich Pharma AG | LYC | Class II | |
| K952618 | Bio-Oss | Geistlich Pharma AG | LYC | Class II | |
| K952554 | Schwartz Electro-Optics, Inc. Trilase Laser System | Schwartz Electro-Optics, Inc. | GEX | Class II | |
| K952512 | Capno-Flo Regulator, Capno-Flo | Kirk Specialty Systems | BTM | Class II | |
| K952405 | Citrace Hospital Germicidal Deodorizer | Caltech Industries, Inc. | LRJ | Class I | |
| K952336 | Dispatch Hospital Cleaner Disinfectant with Bleach | Caltech Industries, Inc. | LRJ | Class I | |
| K951974 | Imagyn Endoscope Sheath | Imagyn Medical, Inc. | GCJ | Class II | |
| K951020 | Tri-Cen Germicidal Detergent | Central Solutions, Inc. | LRJ | Class I | |
| K951018 | Latex Patient Examination Glove Powderfree Laminated Copolymer | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K950825 | Am-Yag | American Lasers, Inc. | GEX | Class II | |
| K950596 | Gdlh Posterior Spinal System | Sofamor Danek USA,Inc. | MNH | Class II | |
| K946140 | Prg Button | Applied Medical Technologies | KNT | Class II | |
| K945480 | Moss(r) Steel Breakaway(r) Introducer | Harry A. Schlakman | KOB | Class II |