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 |
|---|---|---|---|---|---|
| K971022 | Chase Sucker | Chase Medical, Inc. | GCX | Class II | |
| K970834 | Gram Swab | Remel Inc | JTO | Class I | |
| K970778 | Lead Control (Whole Blood) Levels 1,2,3,4 | More Diagnostics Inc. | JJX | Class I | |
| K970580 | Sasi-Dc1ts | Substance Abuse Specialties, Inc. | KDW | Class I | |
| K970382 | Vs-100 Video Sigmoidoscope | Welch Allyn Inc | FAM | Class II | |
| K970373 | Raichem Rheumatoid Factor Spia | Henage Diagnostics, Inc. | DHR | Class II | |
| K965035 | Immage Immunochemistry System Microalbumin (Ma) Reagent | Beckman Instruments, Inc. | JIQ | Class I | |
| K964585 | Resposable Omni Tip(tm) Switchable Tips (Multiple) | Trimedyne, Inc. | GEX | Class II | |
| K963305 | Alexander Box, Battery, Rechargeable | Alexander Mfg. Co. | BWA | Class II | |
| K971040 | Cable Holder, Suction Tube Holder | Domico Med-Device, LLC | GEI | Class II | |
| K970941 | Slippery Glass | Jeneric/Pentron, Inc. | EIH | Class II | |
| K970886 | Hanaulux Blue 80 Hospital | Heraeus Med GmbH | FSS | Class II | |
| K970827 | Precise | Allan Schulman,D.D.S., M.S. | EJH | Class II | |
| K970751 | Heidelberg External Fixator | Smith & Nephew, Inc., Orthopaedic Div. | JDW | Class II | |
| K970719 | 700-Mp Disposable Radiolucent Multi-Pad Electrodes | Cardiotronics Systems, Inc. | MKJ | Class III | |
| K970525 | Statnet | Gorca Systems, Inc. | IZI | Class II | |
| K970495 | Foundation Indirect Composite Resin | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K970439 | Proxiderm (D-460,D 90 460,D 180,460, Ps 460) | Progressive Surgical Products, Inc. | MKY | Class I | |
| K970331 | Cbc-4K Hematology Control | R & D Systems, Inc. | JPK | Class II | |
| K970316 | Innovasive 8Mm Ligament Fastener | Innovasive Devices, Inc. | MBI | Class II | |
| K970246 | Edta Cavit | Karolinski | EBF | Class II | |
| K970224 | Pixi Bone Densitometer | Lunar Corp. | KGI | Class II | |
| K970173 | Model 1700 Tranquility Bilevel System | Healthdyne Technologies, Inc. | BZD | Class II | |
| K970099 | Simon Nitinol Filter/straight Line System | Nitinol Medical Technologies, Inc. | DTK | Class II | |
| K965113 | N-Assay Tia Fibrinogen Test Kit | Crestat Diagnostics, Inc. | KQJ | Class II | |
| K964556 | Hr Polyurethane Picc and Midline Catheters | Johnson & Johnson MEDICAL GmbH | LJS | Class II | |
| K964447 | Picc Catheter/midline Catheter | Menlo Care, Inc. | LJS | Class II | |
| K964307 | Expanded Reference Values for Dpx Bon Densitometers | Lunar Corp. | KGI | Class II | |
| K964200 | Chase Multiple Perfusion Set | Chase Medical, Inc. | DWF | Class II | |
| K964194 | Chase Curved Left Heart Vent Catheter | Chase Medical, Inc. | DWF | Class II | |
| K964193 | Chase Aortic Arch Cannula | Chase Medical, Inc. | DWF | Class II | |
| K964151 | Bard and Bta Test | Bard Diagnostic Sciences,Inc. | MMW | Class II | |
| K963793 | Optivent | Health Care Products, Inc. | CAF | Class II | |
| K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Corp. | GEI | Class II | |
| K960421 | Sinuscan 102/Sinusprint | Ferguson Medical | LWI | Class II | |
| K952905 | Minimatic Various Implant Systems | Minimatic, Inc. | DZE | Class II | |
| K971192 | Impra Eptfe Arteriovenous Cuffed Graft | Impra, Inc. | DSY | Class II | |
| K970953 | E-Type Speed Reducer Contra Angle | Nsk Nakanishi, Inc. | KMW | Class II | |
| K970755 | Stealthshield | Vital Connections, Inc. | DRX | Class II | |
| K970602 | Vaginal 2 Electrode Stimulation/emg Probe-Small | Hollister, Inc. | KPI | Class II | |
| K970533 | Model 1100 Cold Therapy Device | Smith & Nephew, Inc. | ILO | Class II | |
| K970289 | Compressor/nebulizer #3650 | Devilbiss Health Care, Inc. | CAF | Class II | |
| K970164 | Roll Aid | Stand Aid of Iowa, Inc. | ITI | Class II | |
| K970137 | Exl-12Sp,12dp,15dp,20dp Linac | Mitsubishi Electronics America, Inc. | IYE | Class II | |
| K964382 | Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight(19402) | Gibeck, Inc. | CAH | Class II | |
| K962129 | Continuous Flush Device | Merit Medical Systems, Inc. | KRA | Class II | |
| K955666 | Egs4000 | S&P Electrical Industries, Inc. | IPF | Class II | |
| K971211 | Dispens-O-Disc Sparfloxacin | Difco Laboratories, Inc. | JTN | Class II | |
| K971133 | Uric, Ua, or Uric Acid | Carolina Liquid Chemistries | KNK | Class I | |
| K971120 | Dispens-O-Disc (Tm) Levofloxacin | Difco Laboratories, Inc. | JTN | Class II |