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 |
|---|---|---|---|---|---|
| K003077 | Smartscrew Model 222006...227510 | Bionx Implants, Inc. | HWC | Class II | |
| K002973 | Embol-X Introducer, Model Cf00200 | Embol-X, Inc. | DYB | Class II | |
| K002627 | Atrium Medical Corporation Clearway PTFE Balloon Catheter | Atrium Medical Corporation | DXE | Class II | |
| K010894 | Baby Dopplex 3002 (Bd3002) | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K010889 | Baby Dopplex 3000 Mk 2 (Bd3000) | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K010578 | Taga Velocity Passover Humidifier Unit, Model Mp1017 | Taga Medical Technologies, Inc. | BTT | Class II | |
| K010527 | Synthes (USA) Imf Screws | Synthes (USA) Products LLC | DZL | Class II | |
| K010451 | Novametrix Marquette Compatible Sensors | Novametrix Medical Systems, Inc. | DQA | Class II | |
| K010273 | Cranial Molding Orthosis | Orthotic Solutions, Inc. | MVA | Class II | |
| K010245 | Activheal Scar Management Dressing | Advanced Medical Solutions Limited | MDA | Class I | |
| K003206 | Gliasite Radiation Therapy System (Rts), Model 1020,1030,1040,8150,9005 | Proxima Therapeutics, Inc. | KXK | Class II | |
| K011116 | Pasco Mic and Mic/id Panels Inclusion of Esbl Confirmatory Test | Pasco Laboratories, Inc. | LTT | Class II | |
| K011081 | Acumatch M-Series Extra-Small Metaphyseal Segments | Exactech, Inc. | LPH | Class II | |
| K010627 | Powder Free Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | |
| K010625 | Eurospital EU-Ttg Iga Umana | Scimedx Corp. | MVM | Class II | |
| K010550 | Vidas Total Prostate Specific Antigen (Tpsa), Model 30 428 | bioMerieux, Inc. | LTJ | Class II | |
| K010537 | Linezolid Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K010536 | Moxifloxacin Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K010225 | Dosimetry Check | Math Resolutions, LLC | IYE | Class II | |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K000442 | Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,d6651, D66xx | Medical Concepts Development, Inc. | KKX | Class II | |
| K010994 | Take One Bite Modified | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K010709 | Mentor Sterile Saline Mammary Volume Sizers | Mentor | MRD | Unclassified | |
| K010628 | Powdered Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | |
| K010626 | Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | |
| K010508 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | LTT | Class II | |
| K003381 | Shielding Needle Holder | U.S. Safety Syringes Co., Inc. | FMI | Class II | |
| K003275 | Synthes Synmesh Spacer System | Synthes (USA) Products LLC | MQP | Class II | |
| K011053 | Optima | Medical Industries America, Inc. | ITI | Class II | |
| K011003 | Safesting and Safesting Hub | Diasol, Inc | FPA | Class II | |
| K010984 | Emit 2000 Gentamicin Plus Assay | Syva Co., Dade Behring, Inc. | LCD | Class II | |
| K010969 | Neuro N100 Radiofrequency Generator and Accessory Cables | Stryker Corp. | GXD | Class II | |
| K010934 | Emit II Plus Barbituate Assay, Model 0Sr9d0229 | Syva Co., Dade Behring, Inc. | DIS | Class II | |
| K010914 | Beautifil | Shofu Dental Corp. | EBF | Class II | |
| K010880 | Numed High Pressure Pta Catheters | Numed Inc | DQY | Class II | |
| K010840 | Synplug | Isotis NV | LZN | Class II | |
| K010788 | Simplicity Soft Qd Easy Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K010637 | Sonotome Ultrasonic Aspirator Tips | Synergetics Inc | LFL | Unclassified | |
| K010341 | Medtronic Ps Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | Medtronic PS Medical | GWG | Class II | |
| K010314 | Dimension Ctni Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K010313 | Dimension Ctni Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K010255 | Cavity Varnish | Rite-Dent Manufacturing Corp. | LBH | Class II | |
| K010213 | Modification to Cavermap Surgical Aid | Uromed Corp. | ETN | Class II | |
| K003809 | Rapid Drugs of Abuse Single and Multiple Test Panels | Rapid Diagnostics, Inc. | DKZ | Class II | |
| K003440 | Softlase - Surgical Diode Laser System | Zap Lasers, LLC | GEX | Class II | |
| K003145 | Origen Bladder Holder | OriGen Biomedical, Inc. | DWC | Class II | |
| K010890 | Bd Ultra-Fine II Insulin Syringe-Mini Needle, Model 30G * 3/16 (5Mm) | Becton Dickinson & Co | FMF | Class II | |
| K003521 | Dispo-Med 7.6 Liter Sharps Container | Master Benefits, Inc. | FMI | Class II | |
| K010878 | Modification to Immulite Herpes I & II Igg, Model L2khs2 & L2khs6 | Siemens Healthcare Diagnostics Inc. | LGC | Class II | |
| K010853 | Guider Softip Guiding Catheter Xf 5F | Boston Scientific Corporation | DQY | Class II |