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 |
|---|---|---|---|---|---|
| K900942 | Ocular Occluder | Microdynamics | HOY | Class I | |
| K896469 | Eos Inlay Material | Ivoclar North America, Inc. | EBF | Class II | |
| K901989 | Gravity Down Wheelchair Lift | Crow River Industries, Inc. | ING | Class II | |
| K901830 | Chick III Surgical Lighting System | Chick Medical Products | FSY | Class II | |
| K901793 | M.d.c. Porta-Lift | Metal Dynamics Corp. | ING | Class II | |
| K901718 | Klein Lamprey-Cannula(tm) | Jeff Klein Surgical, Inc. | GEA | Class I | |
| K901717 | Klein Micro-Cannula(tm) | Jeff Klein Surgical, Inc. | GEA | Class I | |
| K901695 | Quick Chem II | Seradyn, Inc. | JJQ | Class I | |
| K901438 | Sure-Stop Transbronchial Aspiration Needle | TeleMed Systems | GAA | Class I | |
| K901309 | Sylvan Pediascan 200 Transilluminator | Sylvan Corp. | HJN | Class I | |
| K900759 | Poly-Op (Tm) | Nu-Gyn-Tek, Inc. | OCF | Class II | |
| K900475 | Distrac(tm) Table | Lossing Orthopedic, Inc. | ITH | Class II | |
| K900185 | Niic Model: Dx901 Aspiration System | Niic U.S.A., Inc. | JFL | Class II | |
| K896800 | Irrigation Tray | Westmark, Sterile Packing Systems, Inc. (Sps) | KYZ | Class I | |
| K896713 | Asi Tcu Prostatic Urethroplasty Catheter & Access. | Advanced Surgical Intervention, Inc. | KOE | Class II | |
| K896449 | Im Collagen Shield | Intermedical, Inc. | MOE | Class I | |
| K896420 | Dsl C-Peptide Ria (Dsl #7000) | Diagnostic Systems Laboratories, Inc. | JKD | Class I | |
| K895436 | Modified Minimed III Infusion Pump | Medtronic, Inc. | FRN | Class II | |
| K901818 | Add'l Software Version D2 for Magnetom 42 and 63 | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K901758 | Roche Reagent for Magnesium | Roche Diagnostic Systems, Inc. | JGJ | Class I | |
| K901642 | Widex Hearing Aid Model the Discovery | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K901267 | Coulter Ck (Creatine Kinase) Reagent | Coulter Corp. | CGS | Class II | |
| K901143 | Rep Hemoglobin Ief Kits (Cat. No. 3250) | Helena Laboratories, Corp. | JBD | Class II | |
| K901001 | Uric Acid Test Kit | Elite Technology, Inc. | KNK | Class I | |
| K900846 | Model 366 Hearing Aid | Telex Communications, Inc. | ESD | Class I | |
| K900838 | Transvaginal Transducer Assembly | Pie Medical Equipment B.V. | HGL | Class II | |
| K900831 | Bte Pico Scd, Pico Sc | Phonak, Inc. | ESD | Class I | |
| K900830 | Bte Super-Front Ppcl4, Super-Front Ppc4 | Phonak, Inc. | ESD | Class I | |
| K900829 | Bte Super-Front Ppscl, Super-Front Ppsc | Phonak, Inc. | ESD | Class I | |
| K900773 | Nuclear Max | Scientific Imaging, Inc. | IYX | Class I | |
| K900681 | Panoramic Model X-Caliber X-Ray | Belmont Equipment Corp. | EAP | Class II | |
| K900675 | Phonak Ite 8000, 7000, 6000 Ite Hearing Aid | Phonak, Inc. | ESD | Class I | |
| K897035 | Miracle Ear Model Pc Prog. in-the-Ear Hearing Aid | Miracle-Ear, Inc. | ESD | Class I | |
| K897033 | Widex Bte Hearing Aid Model Q16 with Remote | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K895899 | Flexmedics Guidewire .012 Only | Flexmedics | DQX | Class II | |
| K893863 | Acuson L538 Transducer | Acuson Computed Sonography | ITX | Class II | |
| K901774 | Horizon 2000 Pulse Oximetry (Sao2) Monitor Capabil | Mennen Medical, Inc. | DQA | Class II | |
| K901719 | Klein Micro-Cannula Handle(tm) | Jeff Klein Surgical, Inc. | GEA | Class I | |
| K901709 | Dnp 60-B Unipolar Endocardial Lead | BIOTRONIK AG | DTB | Class III | |
| K901460 | Lsf(tm) Total Hip System | Implant Technology, Inc. | JDI | Class II | |
| K901452 | Usci(r) Access(tm) Introducer Set | C.R. Bard Inc | DYB | Class II | |
| K901338 | Kirschner Modular Tciv Total Knee System | Kirschner Medical Corp. | JWH | Class II | |
| K901328 | Domed and Finned Acetabular Component | Orthomet, Inc. | JDI | Class II | |
| K901251 | Model 9101 Recorder/analyzer System | Aequitron Medical, Inc. | DSH | Class II | |
| K901132 | Sara Satcap | Ppg Industries, Inc. | CCK | Class II | |
| K901120 | Koagulab 60-S Coagulation System | Ortho Diagnostic Systems, Inc. | GKP | Class II | |
| K901114 | Medisonic Humdifier/inhaler | Medisonic U.S.A., Inc. | CAF | Class II | |
| K901061 | Sub-Clavian Catheters Slsc 1300, 1500 and 2000 | Akcess Medical Products, Inc. | LFJ | Class II | |
| K901010 | Flexible Choledochoscope | Intramed Laboratories, Inc. | FBN | Class II | |
| K901002 | O'donnell, Socket Reconstruction Prostheses | Oculo Plastik, Inc. | HQX | Class II |