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 |
|---|---|---|---|---|---|
| K013346 | Gore Drapeable St/lt Regenerative Membrane | W. L. Gore & Associates, Inc. | LYC | Class II | |
| K013320 | Blue Latex Examination Gloves, Powder Free | Arista Latindo Industrial, Ltd. P.T. | LYY | Class I | |
| K013248 | Synthes Lcp Distal Tibia Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K013177 | Multitak Suture Snap System | Bonutti Research, Inc. | GAM | Class II | |
| K013141 | Microgyn Plus Stimulation Device | Hollister, Inc. | KPI | Class II | |
| K013110 | Aniseikonia Inspector | Optical Diagnostics, Inc. | HJT | Class I | |
| K012199 | Digicap | Humana USA, Inc. | GAB | Class I | |
| K012108 | Medpor Coated Tear Drain | Porex Surgical, Inc. | OKS | Unclassified | |
| K981052 | Cresco Ti Implant Concept | Cresco TI Systems AB | DZE | Class II | |
| K014034 | Modification to Synchron Lx Clinical Chemistry Systems (Lx20 and Lx20 Pro) | Siemens Healthcare Diagnostics Inc. | JFL | Class II | |
| K014024 | Modification to Alpha Dx System | First Medical, Inc. | MMI | Class II | |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720 | Radi Medical Systems AB | DSK | Class II | |
| K013907 | Inverness Medical Early Pregnancy Test | Cambridge Diagnostics Ireland, Ltd. | LCX | Class II | |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series | Phoenix Diagnostics, Inc. | CGZ | Class II | |
| K013406 | Advia Centaur Homocysteine Assay | Bayer Diagnostics Corp. | LPS | Class II | |
| K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device | Acon Laboratories, Inc. | DJG | Class II | |
| K013251 | Spirit 300 | Caire, Inc. | BYJ | Class II | |
| K013178 | Dc-Uibc-CO2-Cal, Model Se-153 | Sekisui Diagnostics P.E.I. Inc. | JIX | Class II | |
| K013139 | Stellartech Coagulation System | Stellartech Research Corp. | GEI | Class II | |
| K013019 | Datacaptor | Capsule Technologie | MWI | Class II | |
| K012415 | Auris Aep | Synapsys, Inc. | GWJ | Class II | |
| K012390 | No Step on Site Deug Test Cup | Drug Free Enterprises | LDJ | Class II | |
| K012088 | Nastech Mammary Aspiration Speciman Cytology Test Masct | Nastech Pharmaceutical Company, Inc. | KNW | Class II | |
| K012040 | Ramp Myoglobin Assay | Response Biomedical Corp. | DDR | Class II | |
| K011907 | Snuggle Warm 4000 Convective Warming System | Sims Level 1, Inc. | DWJ | Class II | |
| K010925 | Servoi Ventilator System, Model 64 87 800 E407e | Siemens Elema AB | CBK | Class II | |
| K004047 | Home-Away System | In-X Corp. | CAW | Class II | |
| K002958 | Shapeable Doppler Flow Probe | Cook Vandergrift, Inc. | ITX | Class II | |
| K013972 | H/s Elliptosphere Catheter Set, Model 61-4005 | Ackard Laboratories | LKF | Class II | |
| K013903 | Helical Compression Anchor System, Cannulated, Version 2 | Triad Medical, Inc. | HWC | Class II | |
| K013786 | Drg Orthohex Ss Bone Screw | Doctor'S Research Group, Inc. | HWC | Class II | |
| K013570 | Osseotite Dental Implants | ZimVie US Corp LLC | DZE | Class II | |
| K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | HWC | Class II | |
| K013430 | Ace Bio Win Tibial Nailing System | Depuy Orthopaedics Inc. | HSB | Class II | |
| K013352 | Summit Cemented Hip Prosthesis | Depuy Orthopaedics Inc. | JDI | Class II | |
| K013317 | Tekmedic Powder-Free with Protein Labeling Claim (50 Micrograms or Less) | Tekmedic (M) Sdn Bhd | LYY | Class I | |
| K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim | Medtronic, Inc. | KGO | Class I | |
| K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics LLC. | NHG | Class II | |
| K010850 | Polestar N-10 | Medtronic Navigation, Inc | LNH | Class II | |
| K013939 | Jostra Flowprobe Fp-32E | Jostra AG | DPT | Class II | |
| K013866 | Convoy Advanced Delivery Sheath Kit | Boston Scientific Corporation | DBY | Class I | |
| K013813 | Modification To:apex Medical If-4100 | Apex Medical, Inc. | GXY | Class II | |
| K013703 | Sanyo CO2 Incubators, Models Nos. Mco-17Ac, Mco-17Aic, Mco-20Aic,and Mc0-175M | Sanyo North America Corp. | MQG | Class II | |
| K013541 | Shoulder Coil | GE Healthcare Coils | MOS | Class II | |
| K013538 | Ethanol | Abbott Medical | DML | Class II | |
| K013401 | K-Systems Culture Bag Sealer and Culture Bags Type Cbs-1 and Cb-01 | K-Systems, Kivex Biotec, Ltd. | MQG | Class II | |
| K013327 | Cts-415 | Shantou Institute of Ultrasonic Instuments | IYO | Class II | |
| K013293 | Nipro Hypodermic Needle | Nipro Medical Corporation | FMI | Class II | |
| K013282 | Gore Introducer Sheath | W. L. Gore & Associates, Inc. | DBY | Class I | |
| K013200 | Renmed Contami-Shield Breathing Circuit Sleeve, Model 9999/01 | Rennels Medical Corp. | CAH | Class II |