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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K830957 | Flow-Pac Triglyceride Reagent | Amresco, Inc. | |||
| K830950 | Vascular Products Implantable Pacing | Oscor Inc. | DTB | Class III | |
| K830934 | Quantimetrix Bromeresol Purple Albumin | Quantimetrix Corp. | CJW | Class II | |
| K830932 | Nynex II | La Jolla Technology, Inc. | GZJ | Class II | |
| K830924 | Crm-114 Color Video Camera | Umi, Inc. | FET | Class II | |
| K830909 | Mikro-Tip Cath. Pressure Transducer | Millar LLC. | KRB | Class II | |
| K830900 | Uptake T3 Radioimmunoassay Kit | Medical & Scientific Designs, Inc. | KHQ | Class II | |
| K830896 | Humidifier, with or without Adapter | Airlife, Inc. | KFZ | Class I | |
| K830880 | Immo Phase Direct Progesterone Radio- | Corning Medical & Scientific | JLS | Class I | |
| K830836 | Q.c. Tester | Alltek Filtration, Inc. | LHI | Class II | |
| K830832 | Rheumatoid Factor-Rapid Card Test #65114 | EMD Millipore Corporation | DHR | Class II | |
| K830782 | Lifeline Endocardial Pacing Lead #479-05 | Intermedics, Inc. | DTB | Class III | |
| K830772 | Temp. Pacing Lead, Bipolar #Th60, 90/110 | Oscor Inc. | LDF | Class II | |
| K830761 | Wako Free Cholesterol C Test | FUJIFILM Healthcare Americas Corporation | CHH | Class I | |
| K830733 | Forgarty Chin Peripheral Intraoperative | American Edwards Laboratories | LIT | Class II | |
| K830638 | Physiological Pressure Measurement Sys | Camino Laboratories, Inc. | DXO | Class II | |
| K830630 | Private Labe/ Deodorant Maxipad | Int'L Consumer Disposables | HHL | Class II | |
| K830493 | Protoporphyrin Zn Control | Kaulson Laboratories, Inc. | JJX | Class I | |
| K830210 | Disposable Pressure Transducer | American Pharmaseal Div. Ahsc | DRS | Class II | |
| K823926 | Bed-Check: II-Ifac | Bed-Check Corp. | KMI | Class I | |
| K823860 | Nuclipase (I125) Pancreatic Lipase | Nuclear Diagnostics, Inc. | CET | Class I | |
| K837283 | Unknown | Tannhut | |||
| K837229 | Transducer Models 450, 451, 452, 453, 454 | Hoffrel Instruments, Inc. | |||
| K830473 | Nova Gauze | American Threshold Industries, Inc. | NAB | Class I | |
| K830969 | Perm. Repair Kit for Leonard Norton Dual | Norton Performance Plastics Corp. | LJS | Class II | |
| K830942 | Suction Catheters | Medovations, Inc. | JOL | Class II | |
| K830891 | Specialty Set Model Iv7a01 | Medtronic, Inc. | FPA | Class II | |
| K830868 | Combiset or Infusion Set | Pan-Tek Intl., Inc. | FPA | Class II | |
| K830809 | Grase by Dynamics Ms 27 Syringe Driver | Intermedics, Inc. | FRN | Class II | |
| K830486 | Infusion Pump #As*6h | Baxter Healthcare Corporation | FRN | Class II | |
| K830452 | Pca Pump | Abbott Medical | FRN | Class II | |
| K830282 | Electronic Exercise #313-Pulse Rate | Walton Manufacturer Co. | DRT | Class II | |
| K823899 | Infant Care System | Narco Scientific | FMI | Class II | |
| K837353 | Floatex Ls-22 | Elscint, Inc. | |||
| K837352 | Ceilex Ls-15/Allmec Argostat | Elscint, Inc. | |||
| K831062 | Isolation Mask I.c.s. | American Threshold Industries, Inc. | LGM | Class II | |
| K830939 | Thymine/thymidine Discs Ddg | Oxoid U.S.A., Inc. | JTO | Class I | |
| K830974 | Sutter Cpm 5000 | Sutter Biomedical, Inc. | JFA | Class I | |
| K830970 | Double Lumen Transfer Device | Codan Trading Co. | LHI | Class II | |
| K830961 | Easy Breather Header Bags | Medical Industries Packaging, Inc. | KCT | Class II | |
| K830949 | Polyethylene Medullary Plug - Stiihmer/ | Allo Pro Corp. | LZN | Class II | |
| K830947 | Syringe/needle Dispos-Box-Cutter/crimper | Post Medical, Inc. | |||
| K830945 | Sur-Fit Flexible | Convatec, A Division of E.R. Squibb & Sons | EXB | Class I | |
| K830936 | Treonic Ip5 | Vickers America Medical Corp. | FRN | Class II | |
| K830917 | Surgitek Sizer for Penile Prosthesis | Medical Engineering Corp. | FAE | Class II | |
| K830912 | Tdx T-Uptake | Abbott Medical | KHQ | Class II | |
| K830899 | Three Channel Monitor Series 6700 | Marquette Electronics, Inc. | DXJ | Class II | |
| K830872 | Titan Gel Ldh ISO-Enzyme Control | Helena Laboratories, Corp. | CFE | Class II | |
| K830867 | Reflex One Staple Extractor | Richard-Allan Medical Ind., Inc. | |||
| K830834 | Negative Urine Control | Helena Laboratories, Corp. | JJW | Class I |