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 |
|---|---|---|---|---|---|
| K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | HRS | Class II | |
| K092503 | Radar Vascular Compression Devices | Advanced Vascular Dynamics | DXC | Class II | |
| K092429 | Endogator | Byrne Medical, Inc. | FEQ | Class II | |
| K092420 | Krd1 Pedicle Screw System | SPINEFRONTIER, Inc. dba LESspine Innovations | MNI | Class II | |
| K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra LifeSciences Corporation | JXG | Class II | |
| K091657 | Immunoscan Ccplus | Svar Life Science AB | NHX | Class II | |
| K091263 | Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35) | Materialise N.V. | JWH | Class II | |
| K090682 | Edwards Aquarius System, Model Ge-F098-00 | Edwards Lifesciences Services GmbH | KDI | Class II | |
| K083273 | Microdot Xtra | Cambridge Sensors Limited | NBW | Class II | |
| K092040 | Pherocious 10.5 Fr (24 Cm, 28 Cm and 32 Cm), Models 430102440, 430102840, 430103240 | R4 Vascular, Inc. | LJS | Class II | |
| K091924 | Vps Catheter | Teleflex Medical | LJS | Class II | |
| K091874 | Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656 | Inomed Medizintechnik GmbH | ETN | Class II | |
| K091714 | Alcodigital Breathalyzer, Model At576, At577, At578, At579 | Skyfine Inc. Limited | DJZ | Class I | |
| K090915 | Sterile Water for Inhalation Flex Bag, Usp | Medtronic, Inc. | BTT | Class II | |
| K090888 | Newport Ht70 Family of Ventilators | Newport Medical Instruments, Inc. | CBK | Class II | |
| K083757 | Bpz02 Multipurpose Solution | Bausch & Lomb Incorporated | LYL | Class II | |
| K093423 | Lungpoint Procedure Planning | Broncus Technologies, Inc. | LLZ | Class II | |
| K093389 | Csi Model 5K Managed Health System Kiosk | Computerized Screening, Inc. | DXN | Class II | |
| K093337 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene Sp System | Luminex Corporation | OCC | Class II | |
| K093291 | Varian Interstitial Titanium Needles | Varian Medical Systems, Inc. | JAQ | Class II | |
| K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018 | Inrad | KNW | Class II | |
| K092877 | Indiscal Aspiration Device and Accessories | Baylis Medical Co., Inc. | HRX | Class II | |
| K092737 | Easyra Mg Reagent, Model 10220 | Medica Corp. | JGJ | Class I | |
| K092659 | Spinal USA Rcs Anterior Lumbar Butress Plate System, Model 22-1001-25 | Spinal USA | KWQ | Class II | |
| K092609 | Synthes 3.5 Mm and 4.55 Mm Curved Narrow and Broad Locking Compression Plates (Lcp) | Synthes (USA) Products LLC | HRS | Class II | |
| K092568 | Spartan S3 Facet System | Spinal Elements, Inc | MRW | Unclassified | |
| K092556 | Synthes (USA) 2.4Mm Va-Lcp Two-Column Narrow Volar Distal Radius | Synthes (USA) Products LLC | HRS | Class II | |
| K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25 | Sinexus, Inc. | LYA | Class I | |
| K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | Ophthalmic Imaging Systems | HKI | Class II | |
| K092271 | Ge Logiq E9 Bt2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | IYN | Class II | |
| K092239 | Rosa Surgical Device, Model Rosa 1.1 | MedTech LLC | HAW | Class II | |
| K091973 | Metasul Taper Liners, Metasul Femoral Heads | Zimmer GmbH | KWA | Class III | |
| K091813 | Intrepid Spinal System | Medtronic Sofamor Danek | OVD | Class II | |
| K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | NBW | Class II | |
| K091031 | Pioneer Surgical Nanoss Bvf-E | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K080459 | Chromesytems Toxicology Calibrators and Controls | Chromsystems Instruments & Chemicals GmbH | LAS | Class I | |
| K092549 | Oxiprobe, Models Bm-100, Bm-200, Bm-400, Bm-300, Bm-300S, Bm-600P | Bio Medical Technologies Co., Ltd. | DQA | Class II | |
| K092168 | Elecsys Hcg+b Calcheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K092163 | Full Automatic (Nibp) Blood Pressure Monitor, Model Hl168kb | Health & Life Corporation | DXN | Class II | |
| K092146 | Xtend Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K091815 | Supercheck 1 Blood Glucose Monitoring System, Model 6268 | Biotest Medical Corp. | NBW | Class II | |
| K091664 | Gsd Intense Pulsed Light System, Models: Gp666c4, Gp666c | Shenzhen GSD Tech Co., Ltd | ONF | Class II | |
| K091382 | Kryptonite Bone Cement | Doctor'S Research Group, Inc. | GXP | Class II | |
| K093286 | Powercross .018 Otw Pta Dilation Catheter | Medtronic, Inc. | LIT | Class II | |
| K093089 | Magnum Nail | Robert Reid Inc. | HSB | Class II | |
| K093032 | Triage Total 3 Controls and Calibration Verification Set | Biosite Incorporated | JJY | Class I | |
| K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker | Civco | IYO | Class II | |
| K092113 | Sta - Free Ps Calibrator | Diagnostica Stago, Inc. | JIX | Class II | |
| K091865 | Sport-Elec Body Control System | Sport-Elec | NGX | Class II | |
| K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | HHE | Class II |