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 |
|---|---|---|---|---|---|
| K961609 | Model 1220, or E-Net (54-62 Cm) | Physiometrix, Inc. | GXY | Class II | |
| K961262 | Wallstent Transhepatic Biliary Endoprosthesis/wallstent Endoscopic Biliary Endoprosthesis | Boston Scientific Corporation | FGE | Class II | |
| K961141 | Easy Flex Tens/fes/mns Electrodes 2 Round Model 8200/2X2 Model 8220 | Uni-Patch, Inc. | GXY | Class II | |
| K961120 | Marker System for Stereotaxic Navigation | Howmedica Leibinger, Inc. | HAW | Class II | |
| K960889 | Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips | San Diego Swiss Machining, Inc. | ELC | Class II | |
| K960820 | Sharplan Lasers, Inc. Silktouch Xj Scanner | Sharplan Lasers, Inc. | GEX | Class II | |
| K960593 | Smartmist Asthma Managment System, Smartmist, Model Number Sm-100/Smartmist Spirometry Airway, Model Number Sa-100 | Aradigm Corp. | CCQ | Class I | |
| K960485 | Synchron Systems Iron (Fe)/total Iron Binding Capacity Reagents | Beckman Instruments, Inc. | JMO | Class I | |
| K960470 | Neuro-Patch | Aesculap Inc | GXQ | Class II | |
| K955126 | Lmi Biliary Catheter | Lucas Medical, Inc. | FGE | Class II | |
| K955121 | Heartport Endoarterial Return Cannual | Heartport, Inc. | DWF | Class II | |
| K954775 | Flo-Stat Fluid Monitoring System | Gynecare Innovation Center | HET | Class II | |
| K954585 | Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, Sterile | Rusch Intl. | BTR | Class II | |
| K950482 | Ortho-Mune Ok-Comvo Cd3-Fitc/cd8-Pe (Okt 3/Okt8) Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K961442 | Universal Drainage Tray | Customed, Inc | FCM | Class II | |
| K960799 | Ortho-Ice | Ultimate Wireforms, Inc. | EAT | Class II | |
| K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | MSH | Class II | |
| K960673 | Osap | Snorefree, Inc. | LQZ | Class II | |
| K960632 | Kangaroo Feeding Tube Placment Stylet | Sherwood Medical Co. | KNT | Class II | |
| K960518 | The Puritan-Bennett 318 Plus Nasal CPAP System | Medtronic, Inc. | BZD | Class II | |
| K955851 | Axsym Vancomycin II | Abbott Medical | LEH | Class II | |
| K955519 | Analytical Review Station | Camtronics, Ltd. | IZI | Class II | |
| K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire | Cemax-Icon, Inc. | LLZ | Class II | |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand) | Laerdal Medical a/S | BSR | Class I | |
| K954112 | Vygon Lifevac Mid-Line Tray | Vygon Corp. | FOZ | Class II | |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve) | Advanced Cardiovascular Systems, Inc. | MAV | Class II | |
| K961284 | Kolor + | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K961277 | RF Igm Elisa Test System | Zeus Scientific LLC | DHR | Class II | |
| K961027 | Orthofix Tibial Nailing System | Orthofix SRL | HSB | Class II | |
| K960876 | Five Star Bronchoscope | Five Star Medical, Inc. | EOB | Class II | |
| K960782 | Titanium Tube to Tube Clamp | Synthes (USA) Products LLC | JEC | Class II | |
| K960660 | Hemisphere Acetabular Cup | Ortho Development Corp. | LPH | Class II | |
| K960617 | Advance Tibial Component | Wrightmedicaltechnologyinc | HRY | Class II | |
| K960556 | Bacstop Dental Anti-Retraction Check Valve | Scitech Solutions, Inc. | EIA | Class I | |
| K955728 | Cordis Biliary Stent | Cordis US Corp. | FGE | Class II | |
| K954831 | Orgentec Anti-Rnp/sm Pin Immuno Assay | Orgentec | LKO | Class II | |
| K954830 | Orgentec Anti-Sm(smith) Pin Immuno Assay | Orgentec | LKP | Class II | |
| K954215 | Miniguard | Advanced Surgical Intervention, Inc. | MNG | Class I | |
| K950967 | M.i.c. | V.V.T. Healthcare Technologies, Inc. | JOW | Class II | |
| K961514 | Bcw Advantage Wheelchair | Wheelchairs of Kansas | IOR | Class I | |
| K961473 | Hm-88011 Solid State Electr Surgical Unit | Hill-Med, Inc. | GEI | Class II | |
| K961308 | Audio 'D' Intima Cic | Hearing Solutions, Inc. | ESD | Class I | |
| K961244 | Ksea Instruments for Endoscopic Treatment of Carpal Tunnel Syndrome | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K961226 | Ektachem Clinical Chemistry Calcium (Ca) Slide | Johnson & Johnson Clinical Diagnostics, Inc. | CJY | Class II | |
| K961143 | Telex Select 2-40 with Adaptive Compression S2-40 | Telex Communications, Inc. | ESD | Class I | |
| K961115 | Ektachem Clinical Chemistry Slide Potassium (K+) | Johnson & Johnson Clinical Diagnostics, Inc. | CEM | Class II | |
| K961099 | Ektachem Clinical Chemistry Slide Sodium (Na+) | Johnson & Johnson Clinical Diagnostics, Inc. | JGS | Class II | |
| K961082 | Techna Tone | Techna Tone | ESD | Class I | |
| K961059 | Digifocus Compact | Oticon, Inc. | ESD | Class I |