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 |
|---|---|---|---|---|---|
| K033418 | Tsx-101A/a and Tsx-101A/c Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K033393 | Absolute .035 Self-Expanding Biliary Stent System | Boston Scientific Corporation | FGE | Class II | |
| K033334 | Profile -Er | MEDTOX Diagnostics, Inc. | DIS | Class II | |
| K033241 | Be-Mobile 3-Wheeled Electric Scooter, Model Dk S320 | Tung Keng Enterprise Co., Ltd. | INI | Class II | |
| K033032 | Wu's 3-Wheeled Neo Scooter, Model Wt-M3jr | Wu's Tech Co., Ltd. | INI | Class II | |
| K032880 | Summit Stairway Lift | Summit Lifts, Inc. | ILK | Class II | |
| K032871 | Planet Monitoring System | Larsen & Toubro Limited | MWI | Class II | |
| K032867 | Star (Lunar Series) Monitoring System | Larsen & Toubro Limited | MWI | Class II | |
| K032823 | Medicheart, Model Release 1 | Medicsight | JAK | Class II | |
| K032607 | Powerpro Pneumatic System, Models Pro6150, Pro6175, Pro6185 | Linvatec Corporation | DZI | Class II | |
| K032536 | Somatom Extended Field of View Software Option | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K032475 | Somaton Computed Tomography X-Ray Systems Sliding Gantry Option | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K032308 | Blood Pressure Monitor, Model M100 | Meditek Technology, Inc. | DXN | Class II | |
| K031834 | Xpect Giardia/cryptosporidium Lateral Flow Assay | Remel Inc | MHI | Class II | |
| K031795 | Reliant Laser System | Reliant Technologies, Inc. | GEX | Class II | |
| K031385 | Anzai Az-733 Respiratory Gating System | Anzai Medical Co, Ltd. | LHN | Class II | |
| K030583 | Powder-Free Latex Examination Gloves with Protein Labeling Claim (Containes 50 Micrograms or Less of Total Water Extrace | Shen Wei (USA), Inc. | LYY | Class I | |
| K033430 | 3I Tg Osseotite Implant, Models Tg685, Tg610, Tg611, Tg613, Tg5685, Tg5610, Tg5611, Tg5613, Tg5615 | ZimVie US Corp LLC | DZE | Class II | |
| K033385 | Dgh 55 Handheld Pachymeter (Pachmate) | DGH Technology, Inc. | IYO | Class II | |
| K033061 | Calibrating Material, Ise Electrolyte Reference | DIAMOND DIAGNOSTICS Inc | JIX | Class II | |
| K032873 | Proclear Compatibles Multifocal | CooperVision, Inc. | LPL | Class II | |
| K032697 | Dimension Total Triiodothyronine Calibrator (Rc414) | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K032647 | Aloetouch Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Colour and Coated with Aloe Vera | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K032473 | Dekompressor Percutaneous Discectomy Probe | Stryker Corp. | HRX | Class II | |
| K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | EMA | Class II | |
| K033425 | Ambit Intermittent Ambulatory Infusion Pump | Sorenson Medical, Inc. | FRN | Class II | |
| K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | OEB | Class II | |
| K033365 | Apexpro Fh Telemetry System | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K033325 | Ambit Continuous Ambulatory Infusion Pump | Sorenson Medical, Inc. | FRN | Class II | |
| K033275 | Lifepak 12, 20, 500, Cr Plus | Physio Control, Inc. | MKJ | Class III | |
| K033271 | Dynalok Classic Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K033245 | Bard Ultraview Multiple Band Ligator, Model 00700U | C.R. Bard Inc | MND | Class II | |
| K030419 | Viterion 100 Telehealth Monitor | Viterion Telehealthcare, LLC | MWI | Class II | |
| K030359 | Kd-726 Memory Wrist Automatic Electronic Blood Pressure Monitor | Kodon(Tianjin)Electronic&Electrical Apparatus Co. | DXN | Class II | |
| K033416 | Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface | Medtronic Perfusion Systems | DWF | Class II | |
| K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180Plus Ultrasound System, Model L03073, L02245, L02464 | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K033361 | Viatronix V3d Vascular, Revision 1.0 | Viatronix, Inc. | LLZ | Class II | |
| K033321 | Selectiva Sb Guidewire | Neometrics, Inc. | DQX | Class II | |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers | Ortho-Clinical Diagnostics, Inc. | DDR | Class II | |
| K033247 | Medrad Spectris Solaris Mr Injector System | Medrad, Inc. | DXT | Class II | |
| K033233 | Lactosorb Tibial L-15 Screw and Washer | Zimmer GmbH | HWC | Class II | |
| K033224 | Hologic Qdr Explorer X-Ray Bone Densitometer, Model Explorer | Hologic, Inc. | KGI | Class II | |
| K033158 | Synthes Reprocessed External Fixation Devices | Synthes (USA) Products LLC | KTT | Class II | |
| K033145 | Hoffmann II Pelvic Clamp | Howmedica Osteonics Corp | LXT | Class II | |
| K033112 | Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models Cfd-347, Cfd-347-Ns | Hand Biomechanics Lab Inc | KTT | Class II | |
| K033102 | Medic Colon Model, Release 1 | Medicsight | JAK | Class II | |
| K033093 | Echoconnex Communicator | Connexmd | LLZ | Class II | |
| K033071 | Synthes (USA) Cannulated Titanium Humeral Nail System | Synthes (USA) Products LLC | JDS | Class II | |
| K033034 | Versys Beaded Fullcoat Calcar Hip Prosthesis | Zimmer GmbH | LPH | Class II | |
| K032470 | Multilink | Ivoclar Vivadent, Inc. | EMA | Class II |