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 |
|---|---|---|---|---|---|
| K951940 | Patient Examination Glove | Lowenkamp Intl., Inc. | LYY | Class I | |
| K951717 | Med-Tec Knee Crutch | Medtec LLC | IYE | Class II | |
| K951704 | Non-Woven Filter Paper for Steam and Gas Sterilization | Products for Medicine | FRG | Class II | |
| K951703 | Tamper Evident Arrows with and without Sterilization Indicators | Products for Medicine | LRT | Class II | |
| K951469 | Bazooka System | Innovative Medical Systems, Inc. | FNM | Class II | |
| K950995 | Sensicare Synthetic, Surgical Glove Liner | BD Becton Dickinson Vacutainer Systems Preanalytic | LYN | Class II | |
| K950868 | Beltone Composer 2000 | Beltone Electronics Corp. | ESD | Class I | |
| K950785 | Hortmann Airmatic Air Caloric Stimulator | JEDMED Instrument Company | KHH | Class I | |
| K950554 | North Bloodborne Pathogen Response Kit | North Safety Products | FXX | Class II | |
| K950032 | Mediskin(r) Ss, Zenoderm Biological Wound Dressing | Brennen Medical, Inc. | KGN | Unclassified | |
| K946003 | Intec Full Face Shield | Intec Industries, Inc. | LYU | Class I | |
| K945626 | Quinton Model 710 Stress Electrocardiograph | Quinton, Inc. | DPS | Class II | |
| K945540 | Caas II | Pie Medical Equipment B.V. | IZI | Class II | |
| K943591 | Vector(tm) Ambulatory Drug Delivery System | Infusion Technology Intl. | FPA | Class II | |
| K942810 | Palco Labs Cold Pouch | Palco Laboratories, Inc. | LDQ | ||
| K942196 | 3050 Diascope Nt Patient Monitor | S & W Medico Teknik | DSI | Class II | |
| K951580 | Fc-38Lh, Fiber Colonosccope | Pentax Precision Instrument Corp. | FDF | Class II | |
| K951578 | Fc-38Lx, Fiber Colonoscope | Pentax Precision Instrument Corp. | FDF | Class II | |
| K951575 | Fc-38Tlh, Fiber Colonoscope | Pentax Precision Instrument Corp. | FDF | Class II | |
| K951573 | Fs-38H, Fiber Sigmoidoscope | Pentax Precision Instrument Corp. | FAM | Class II | |
| K951572 | Fs-38X, Fiber Sigmoidoscope | Pentax Precision Instrument Corp. | FAM | Class II | |
| K951313 | Medamicus Percutaneous Introducer | Greatbatch Medical | DYB | Class II | |
| K951303 | Sfc | Medpac | HWC | Class II | |
| K951001 | Flexicair Exlipse | Hill-Rom Inc. | IOQ | Class II | |
| K946306 | Siemens Sc 9000 Bedside Monitor, Sc 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K945198 | Dideco Pediatric Arterial Filters | Sorin Biomedical, Inc. | DTM | Class II | |
| K943390 | Flexfinder Guidewire | Flexmedics | DQX | Class II | |
| K936156 | Ventilation Mechanics Monitor Model Vmm-100 | Smith Industries Medical Systems (Sims) | MOD | Class II | |
| K932622 | Cholera Smart(tm) | New Horizons Diagnostics Co. | GSQ | Class II | |
| K952556 | Safetex Super Hypoallergenic Powdered Latex Examination Glove | Aladan Corp. | LYY | Class I | |
| K952538 | Robert B. Scott Plastic Artifical | Robert B. Scott Ocularists of Florida, Inc. | HQH | Class I | |
| K952235 | Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15 | Medrad, Inc. | LNH | Class II | |
| K952232 | Mrinnervu Disposable Endorectal Colon Coil, Catalong No. Pcc-15 | Medrad, Inc. | LNH | Class II | |
| K951815 | Sunglasses | Fung Won Optical Mfg. Co. | HQY | Class I | |
| K951552 | Boston Contact Lens Case | Polymer Technology Corp. | LRX | Class II | |
| K951244 | Spine Tuner Posture Trainer | Dan Kline | LZW | Unclassified | |
| K951132 | Angioscan (as Stand Alone Instrument) | Carl Zeiss Meditec Inc | HLI | Class II | |
| K950940 | Opti Pads | Karlen Mfg., Inc. | LYL | Class II | |
| K946299 | Pgs123 and Hvs-123 | Skylark Device Co., Ltd. | GZJ | Class II | |
| K941898 | Memorytrace Atm Model 4222 | Hi-Tronics Designs, Inc. | DXH | Class II | |
| K941678 | Bionector | Vygon Corp. | FOZ | Class II | |
| K941439 | Renalin Cold Sterilant | Medivators Inc | LRJ | Class I | |
| K933148 | Surgical Drape Kit | Nobelpharma USA, Inc. | KKX | Class II | |
| K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | GEI | Class II | |
| K952644 | Steri-Oss Self Taping Implant | Steri-Oss, Inc. | DZE | Class II | |
| K952484 | Modem Transfer Application Software Nsmd-001A & Nsmd-070A | Toshiba America Medical Systems, In.C | LMD | Class I | |
| K952414 | Prefilled Syringe for Inflation of Foley Catheter | Acacia Laboratories, Inc. | KNY | Class II | |
| K952412 | Dupont Aca(r) Urine Druge Os Abuse Control | Dupont Medical Products | DIF | Class I | |
| K952323 | Mist Electrosurgical Probes, Various Styles & Sizes | Mist, Inc. | JOS | Class II | |
| K952290 | Mist Electrosurgical Probes, Various Styles & Sizes, Surgical Instruments Used During Endoscopic Procedures | Mist, Inc. | JOS | Class II |