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 |
|---|---|---|---|---|---|
| K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | DXZ | Class II | |
| K050468 | Triabsorb Composite Screw | Advanced Biomaterials | HWC | Class II | |
| K050421 | Ms 4/5 Hematology Analyzer | Melet Schloesing Laboratories USA | GKZ | Class II | |
| K042915 | O'my Natural Lubricant, O'my Natural Flavored Lubricant | O'My Products Incorporated | NUC | Class II | |
| K052129 | Lumenis 1000 Integrated Slit Lamp | Lumenis Ltd | GEX | Class II | |
| K051979 | Ors Model 6000 Endoscope Holder | O.R. Solutions, Inc. | OCT | Class II | |
| K051889 | Carevent Ca and Dra | O-Two Medical Technologies, Inc. | BTL | Class II | |
| K051657 | A-Dec Self-Contained Water System | A-dec, Inc. | EIA | Class I | |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | NEU | Class II | |
| K051380 | Triathlon Press-Fit Total Knee System | Howmedica Osteonics Corp | MBH | Class II | |
| K051301 | Proximate Pph Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K052072 | The Sc-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates | Spinal Concepts, Inc. | KWQ | Class II | |
| K052067 | Doppler Guided Proctoscope, Model 500H | Multigon Industries, Inc. | JAF | Class II | |
| K051905 | Uroplasty Rigid Endoscopic Needle | Uroplasty, LLC | FBK | Class II | |
| K051413 | Isis Iq Duo Twin Electronic Breast Pump, Model 100 | Avent America, Inc. | HGX | Class II | |
| K051177 | PVC and Silicone Manual Resuscitators | David Medical Products Co.,Ltd | BTM | Class II | |
| K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard Inc | DTK | Class II | |
| K050269 | U1 Hip System - Bipolar | United Orthopedic Corp. | KWY | Class II | |
| K042758 | Polytech Pulmonary Function Filter | Polytechnic Resources, Inc. | BZG | Class II | |
| K052101 | C.f.a.s. (Calibrator for Automated Systems) Hba1c | Roche Diagnostics GmbH | KRZ | Class II | |
| K052066 | Ceegraph/sleepscan Netlink Traveler | Bio-Logic Systems Corp. | OLV | Class II | |
| K052049 | Philips 12-Lead Algorithm | Philips North America LLC | DPS | Class II | |
| K051816 | Lumiwave 1X4 Infrared Therapy Device | Biocare Systems, Inc. | ILY | Class II | |
| K051574 | Nipro Disposable Syringe with or without Needle | Nipro Medical Corporation | FMF | Class II | |
| K051296 | Sijf Cannulated Screw System | DePuy Spine, Inc. | OUR | Class II | |
| K051171 | Stingray Epidural Catheter Connector | Epimed International, Inc. | CAZ | Class II | |
| K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | LJS | Class II | |
| K050399 | MRI Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | MWI | Class II | |
| K050170 | Fortoss Vital Bone Graft Substitute | Biocomposites, Ltd. | LYC | Class II | |
| K052157 | Innova CT Option for Digital Fluoroscopic Imaging Systems Innova Models 4100, 4100Iq, 3100, 3100Iq & 2100Iq | GE Healthcare | JAK | Class II | |
| K052136 | Gr17 Digital Detector | Anrad Corp. | MQB | Class II | |
| K052114 | Bard Conformexx Biliary Stent with the Performaxx Grip | Bard Peripheral Vascular Inc | FGE | Class II | |
| K052080 | Matryx Interference Screw | Linvatec Biomaterials, Ltd. | HWC | Class II | |
| K052064 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | KTT | Class II | |
| K052062 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | KTT | Class II | |
| K052036 | Atb Advance Pta Dilatation Catheter | Cook Inc. | DQY | Class II | |
| K052022 | Asahi Ptca Guide Wire Fielder | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K051962 | Ultra Hdl | Abbott Medical | LBS | Class I | |
| K051115 | Sentinel Iron Liquid | Sentinel CH SpA | JIY | Class I | |
| K050234 | Remote Care | E.Care Solutions, Inc. | HGM | Class II | |
| K052194 | Spyglass Direct Visualization Probe and Ocular | Boston Scientific Corporation | ODF | Class II | |
| K052132 | Modification to: Lifestent Valeo Biliary Stent System | Edwards Lifesciences LLC | FGE | Class II | |
| K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5 | Abbott Medical | FRN | Class II | |
| K052045 | Access Breast Coil | Confirma, Inc. | MOS | Class II | |
| K050896 | H12+ Holter Recorder | Mortara Instrument, Inc. | DSH | Class II | |
| K050764 | Uniglide Unicondylar Knee Prosthesis | Corin USA | HRY | Class II | |
| K050336 | Opd-Station Software | Nidek, Inc. | NCF | Class I | |
| K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular Inc | DQY | Class II | |
| K052188 | Cutaneous Electrode | Rhythmlink International, LLC | GXY | Class II | |
| K052180 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II |