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 |
|---|---|---|---|---|---|
| K902889 | A1-A,a1-B,a1-Abp,a1-Mbp,a1-Z,a6-A,a6-B,peh Pace. | BIOTRONIK AG | DTD | Class II | |
| K902758 | Cobe Saturation/hematocrit Monitor W/ Fiber Optic | Cobe Laboratories, Inc. | DQA | Class II | |
| K902652 | Mortara Instrument Model Eli 50 | Mortara Instrument, Inc. | DRT | Class II | |
| K902508 | Lake Male External Catheterization Kit | Lake Medical Products, Inc. | FCM | Class II | |
| K902486 | Cardiovista | Cardionostics, Inc. | DSH | Class II | |
| K902472 | Morse Dt Manifold | North American Instrument Corp. | DRS | Class II | |
| K902469 | Byrd Dilator Sheath Set - Teflon | Medical Engineering and Development Institute | DRE | Class II | |
| K902453 | Oscillometric Pulse Detection Device | Thomas J. Fogarty, M.D. | DRS | Class II | |
| K902441 | Disposable Procedural Trays #Ck-Xxxxx (Various) | Currie Medical Specialties, Inc. | KDD | Class I | |
| K902355 | Mcr4000 & Mcr4000f Cardiotomy Reservoir | Medtronic, Inc. | DTP | Class II | |
| K902339 | Theraview Digital Portal Imaging Computer | S & S Inficon, Inc. | IYE | Class II | |
| K902192 | Model Msc Sa02-5000 Pulse Oximeter | Medical Systems Corp. | DQA | Class II | |
| K902044 | Mega 4 Magnetic Resonance Imaging System | Instrumentarium Imaging, Inc. | LNH | Class II | |
| K901817 | Fukuda Denshi Model Fx-3101 | Fukuda Denshi USA, Inc. | DPS | Class II | |
| K901504 | Models 706 Ecg/pressure/resp./sao2, 705 Ecg/resp. | Ivy Biomedical Systems, Inc. | DQA | Class II | |
| K901392 | Bp50 Blood Pressure and Pulse Monitor | Pulse Time Products, Ltd. | DXN | Class II | |
| K901225 | Life Shield (Disposable Pressure Infusor) | Abbott Medical | KZD | Class I | |
| K901072 | Centralscope 12 | Marquette Electronics, Inc. | DXJ | Class II | |
| K900978 | Manan Arterial Catheter Needle | Argon Medical Devices, Inc | DQY | Class II | |
| K900805 | Aloka 500 Diagnostic Ultrasound Scanning System | GE Medical Systems Information Technologies, Inc. | IYO | Class II | |
| K900658 | Introducer, Percutaneous | Novoste Puerto Rico, Inc. | DYB | Class II | |
| K900515 | Models 6207/6208/6209/6210/6211/6212/6214 (Pli's) | Medtronic, Inc. | DYB | Class II | |
| K897077 | Accuprobe Mycobacterium Intracellulare Culture | Hologic, Inc. | LQF | Class I | |
| K896494 | Accuprobe Mycobacterium Avium Culture Test | Hologic, Inc. | LQF | Class I | |
| K903425 | Haemophilus Test Medium (Htm) Broth | BD Becton Dickinson Vacutainer Systems Preanalytic | JSO | Class II | |
| K903402 | Geohesive (Tm), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | GXY | Class II | |
| K903359 | Microzyme Unconjugated Estriol Enzyme Immuno Kit | IMMUNOTECH s.r.o. | CGI | Class I | |
| K903341 | Magnesium | Catachem, Inc. | JGJ | Class I | |
| K903316 | Aloka Ust-964P-5 Endovaginal Transducer | GE Medical Systems Information Technologies, Inc. | HGL | Class II | |
| K903194 | Reditest Strep a Test Kit | Boehringer Mannheim Corp. | GTZ | Class I | |
| K903192 | Il Tobramycin Assay | Instrumentation Laboratory Co. | KLB | Class II | |
| K903189 | Kodatrol Liquid Control Levels I & II | Eastman Kodak Company | DIF | Class I | |
| K903101 | Innofluor (Tm) Amikacin Calibrator Set | Innotron of Oregon, Inc. | DLJ | Class II | |
| K902952 | Il Phenytoin Assay System | Instrumentation Laboratory Co. | DIP | Class II | |
| K902909 | Clp Low Level Hdl Cholesterol -Lipid Control | Creative Laboratory Products, Inc. | JJY | Class I | |
| K902734 | Pr Cannulas | Olympus Corp. | FGE | Class II | |
| K902733 | 1St Response (Tm) Infant Manual Resuscitator | Intertech Resources, Inc. | BTM | Class II | |
| K902639 | Epo-Trac(tm) 125I Radioimmunoassay (Ria) | Incstar Corp. | GGT | Class II | |
| K902467 | Flora-Stat Urine Transport System | Wadley Biosciences Corp. | LIO | Class I | |
| K902445 | Lympho Sep(tm) | Icn Biomedicals, Inc. | JCF | Class I | |
| K902391 | Cell-Dyn 3000 Control | Unipath, Ltd. | JCN | Class II | |
| K902389 | Tri-Count 16 | Hematronix, Inc. | JCN | Class II | |
| K902335 | Natural-Knee System System W/cocr/csti(tm) | Intermedics Orthopedics | JWH | Class II | |
| K902329 | Ultra-Vu Angioscope | Angiolaz, Inc. | LYK | Class II | |
| K902298 | Oral-Nasal Mask Resuscitation and Anesthetic Gas | Rondex Products, Inc. | BSJ | Class I | |
| K902204 | Stanbio Csf/urine Total Protein Test Set | Stanbio Laboratory | JIR | Class I | |
| K902111 | Modified Freeman Revision Acetabular Cup | Turnkey Intergration USA, Inc. | KWA | Class III | |
| K902110 | Modified Freeman Acetabular Cup | Turnkey Intergration USA, Inc. | KWA | Class III | |
| K901263 | Navion Smart-Wire(tm) Catheter Location System | Navion Biomedical Corp. | FOZ | Class II | |
| K901142 | Mer Multiplane Vaginal Probe (Mvp) | Medical Equipment Resources | HGL | Class II |