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 |
|---|---|---|---|---|---|
| K984579 | Capno Probe a | Optical Sensors, Inc. | CCK | Class II | |
| K003734 | Serum Protein Substitute | Sage Biopharma | MQL | Class II | |
| K003724 | Cbmyotherm Xp Cardioplegia Delivery System with Carmeda Bioactive Surface, Models Cb41 and Cb41-B | Medtronic, Inc. | DTR | Class II | |
| K003681 | Bio-Logic Sleepscan Netlink | Bio-Logic Systems Corp. | OLV | Class II | |
| K003634 | Dw 272 #1 | Ivoclar North America, Inc. | EJT | Class II | |
| K003623 | Interactive Real Time Scanning Package | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K003598 | Datascope Profile 8Fr. Alt B Iab, 34Cc, Datascope Profile 8Fr. Alt B Iab, 40Cc, Model 0684-000319, 0684-00-0320 | Datascope Corp. | DSP | Class II | |
| K003547 | Nugard Dg Powdered Green-Mint Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less) | Terang Nusa (Malaysia) Sdn. Bhd. | LYY | Class I | |
| K003545 | Nugard Powderfree, Blue Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Le | Terang Nusa (Malaysia) Sdn. Bhd. | LYY | Class I | |
| K003371 | Pump Tubing with X-Coating | Terumo Corp. | DWF | Class II | |
| K003337 | Hem-O-Lok Smx, Model 544220; Hem-O-Lok Ml, Model 544230; Hem-O-Lok Mlx, Model 544240 | Weck Closure Systems | FZP | Class II | |
| K003277 | Surgassist System with Circular Stapler Disposable Loading Unit, Model Cs21,cs25,cs29,cs33 | Powermed, Inc. | GDW | Class II | |
| K003264 | Qps/bpgs/moco Processing Applications for Entegra Workstation | GE Medical Systems F.I. Haifa | KPS | Class II | |
| K003248 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | MHX | Class II | |
| K003246 | Siemens Multi View Workstation with Vent Viewer Option | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K003243 | Siemens Infinity Modular Monitors Model Sc 8000; Sc 7000; Sc 9000Xl | Siemens Medical Solutions USA, Inc. | MHX | Class II | |
| K003192 | Magnetic Concerto | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K002955 | Empire N Blood Pressure Manometers | Rudolf Riester GmbH & Co. KG | DXQ | Class II | |
| K002954 | Ri-San/ri-Sana Blood Pressure Manometers | Rudolf Riester GmbH & Co. KG | DXQ | Class II | |
| K002425 | Mediadent Hdx/mmd Hdx Sp XRAY Sensor | Multi Media Dental Systems, Inc. | MUH | Class II | |
| K002122 | Vector | Air Techniques, Inc. | ELC | Class II | |
| K001634 | Cardiosentry Event Monitor, Model 8470-01 | TZ Medical Inc. | DXH | Class II | |
| K000714 | Vacuflow+safe Blood Collection Set and Vacuflow+safe with Holder Blood Collection Set | Med-Pro Technologies, Inc. | FMI | Class II | |
| K003781 | Cooltouch Varia-II Nd:yag Laser System | Cooltouch Corp. | GEX | Class II | |
| K003772 | Elecsys Dhea-S Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K003730 | Chemo-Aide Dispensing Pin | Baxter Healthcare Corporation | LHI | Class II | |
| K003728 | Modification to Aequalis Shoulder Fracture System | TORNIER Inc. | KWS | Class II | |
| K003716 | Conformance Chemistry Control C3 | Consolidated Technology | JJY | Class I | |
| K003642 | Placement-Plus | Catheter Innovations, Inc. | LJS | Class II | |
| K003633 | Dw 277 #4 | Ivoclar North America, Inc. | EJT | Class II | |
| K003632 | Dw 273 #1 | Ivoclar North America, Inc. | EJS | Class II | |
| K003624 | Refinity System, Refinity Handpiece and Cable, Refinity Footswitch, Refinity Power Cord, Model V5100-00,V5701-00,V5702 | ArthroCare Corporation | GEI | Class II | |
| K003621 | St/ar St and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | MHX | Class II | |
| K003565 | Heartstream Fr2 AED, Model M3860a,m3861a | Agilent Technologies, Inc. | MKJ | Class III | |
| K003564 | Hakim Programmer and Transmitter | Cerenovus, Inc. | JXG | Class II | |
| K003118 | Z2 Balloon Guided Pacing & Pressure Monitoring Catheter, Model Z2-7-02-1-10-0 | Zcv,Inc. | DYG | Class II | |
| K003100 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System | Boston Scientific Corporation | JCT | Class II | |
| K002925 | Coolblu Curing Light | Dental Systems.Com, Inc. | EBZ | Class II | |
| K002854 | Gold Core Post Solder | Jeneric/Pentron, Inc. | EJT | Class II | |
| K002550 | Rdh Bandage | Marine Polymer Technologies, Inc. | KMF | Class I | |
| K002308 | Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-Vhp and 1500-a | Trimedyne, Inc. | GEX | Class II | |
| K001763 | Crit-Line Monitor III (Clm III) | In-Line Diagnostics Corp. | MQS | Class II | |
| K003569 | Plasmakinetic Endourology System | Gyrus ACMI, Inc. | KNS | Class II | |
| K003280 | Variant II Total Ghb | Bio-Rad | LCP | Class II | |
| K003115 | Actis Adjustable Constriction Loop | Vivus, Inc. | LKY | Class II | |
| K002964 | Neuro II | Innovative Magnetic Resonance Imaging Systems, Inc. | LNH | Class II | |
| K002947 | Biomol Aspiration Biopsy Needle | H.S. Hospital Service S.p.A. | FCG | Class II | |
| K002946 | Silent Biopsy Needle | H.S. Hospital Service S.p.A. | FCG | Class II | |
| K002944 | Precisa Biopsy Needle | H.S. Hospital Service S.p.A. | FCG | Class II | |
| K002942 | Philips Easy Vision Family Workstation Option Cardirac Scoring | Philips North America LLC | LLZ | Class II |