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 |
|---|---|---|---|---|---|
| K952447 | Hill-Rom Ambulatory Care Procedural Stretcher | Hill-Rom Inc. | FPO | Class II | |
| K951139 | Alpha Long Stem Femoral Component (Subject to Wmti Marketing Approval) | Wrightmedicaltechnologyinc | JDI | Class II | |
| K951097 | Bodystay | Bodystat Ltd | DSB | Class II | |
| K950630 | Wallach Digital Imaging System | CooperSurgical, Inc. | LMB | Class I | |
| K946175 | Nihon Kohden Zb-831Pa Telemetry Transmitter | Nihon Kohden America Inc | DRG | Class II | |
| K944473 | Xchf-33 Choledochofiberscope | OLYMPUS Corporation of the Americas | FBN | Class II | |
| K954825 | Access Hypersensitive Tsh Reagents on the Access Immunoassay Analyzer | Bio-Rad Laboratories Inc. | JLW | Class II | |
| K954180 | Microgliss | Espe GmbH & Co. KG. | ELW | Class II | |
| K954138 | Duracon Monolithic Stabilizer Femoral Component | Howmedica Corp. | JWH | Class II | |
| K954123 | Low Profile Safsite Y-Site | B.Braun Medical, Inc. | FPA | Class II | |
| K954104 | Per-Q-Cath & per-Q-Cath Dual Mumen Catheters, Trays & Accessory Devices | C.R. Bard Inc | LJS | Class II | |
| K954102 | Selectmucus | Select Medical Systems, Inc. | HFC | Class II | |
| K954097 | Selectcells Standard | Select Medical Systems, Inc. | HHK | Class II | |
| K954064 | Becton Dickinson Syringse | BD Becton Dickinson Vacutainer Systems Preanalytic | FMF | Class II | |
| K953999 | Dantec Da Capo | Dantec Medical, Inc. | EXY | Class II | |
| K953905 | Imperium | Teledyne Brown Engineering | IQA | Class II | |
| K953470 | Flushies Flushable/biodegradable Menstrual Pads/napkins (Ultra Thins) | Mediquip, Inc. | HHD | Class I | |
| K953345 | Genesis | Tecan U.S. | JQW | Class I | |
| K952875 | Accu-Chek Alpha Monitor & Accu-Chek Glucose Test Strips | Boehringer Mannheim Corp. | CGA | Class II | |
| K952625 | Coaguchek System | Boehringer Mannheim Corp. | JPA | Class II | |
| K952231 | Emc Model Statome 200 | Emc Industries | GEI | Class II | |
| K952167 | Imz Bone Tack System | Interpore Intl. | DZL | Class II | |
| K951727 | Z-Watch System | Prizm Medical, Inc. | IPF | Class II | |
| K951266 | Amset R-F System | Advanced Spine Technology, Inc. | MNH | Class II | |
| K951217 | Atlas Orthogonal Percussion Insttument | Sweat Chiropractic Clinic | LXM | Unclassified | |
| K950490 | Medtronic Gc IV Coronary Guiding Catheter | Medtronics Interventional Vascular | DQY | Class II | |
| K946109 | Cabot Medical Reusable Bipolar Cutting Forceps | Cabot Medical Corp. | KNS | Class II | |
| K946087 | Inclusice Ii(tm) Endoscope | Sofamor Danek USA,Inc. | HRX | Class II | |
| K945072 | Siemens Q4000 | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K943200 | Floscope Super Vascular Lab | Advance Medical Device, Inc. | JAF | Class II | |
| K922567 | Low Profile Catheter | Rusch, Inc. | KNT | Class II | |
| K954732 | Access Total Bhcg Assay (Modification) | Bio-Rad Laboratories Inc. | JHI | Class II | |
| K954590 | Max-1000A/r1 | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K954291 | Opus Tdm Controls | Behring Diagnostics, Inc. | DIF | Class I | |
| K954229 | Argon Accessory with Blade & Needle Electrode, Adapter Box | Medtronic, Inc. | GEI | Class II | |
| K954190 | Model 580Ge-64 Quadrature Abdominal Flex Coil | Medical Advances, Inc. | MOS | Class II | |
| K954048 | Variant Hemoglobinopathy Program | Bio-Rad | GKA | Class II | |
| K954015 | Abg Point Lok Needle Protection Device | Devon Industries, Inc. | CBT | Class I | |
| K953935 | Med-Tech Clinical Blood Gas | Medical Technical Gases Inc. | CHL | Class II | |
| K953837 | Biocircuits Ios T4 Test Cartridge | Biocircuits Corp. | KLI | Class II | |
| K953714 | Zimmer Reconstruction System Symphyseal Bone Plate | Zimmer GmbH | HRS | Class II | |
| K953302 | Facs Loader System | Becton Dickinson Immunocytometry Systems | GKZ | Class II | |
| K953247 | Gibson Id A.e. Test | Microbiologics, Inc. | JTO | Class I | |
| K952818 | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | Pyramid Biological Corp. | GMM | Class II | |
| K952751 | Biocircuits Ios T4/tu Test Cartridges | Biocircuits Corp. | KLI | Class II | |
| K952727 | Mrc-5 Cell Culture Vial | Viratest Intl., Inc. | KIR | Class I | |
| K952514 | Coacute Heparin | Chromogenix AB | KFF | Class II | |
| K952467 | Trend Giardia Lamblia Direct Detection System (Modified Kit) | Trend Scientific, Inc. | MHI | Class II | |
| K951946 | Hysterosys Flexible Hysterocope | Ovamed Corp. | HIH | Class II | |
| K951364 | Microsomal Eia Test Kit | Immunoprobe, Inc. | JNL | Class II |