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 |
|---|---|---|---|---|---|
| K994318 | Vistakon (Lenefilcon A)soft(hydrophilic)contact Lens Clear and Visibility Tinted with UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | LPL | Class II | |
| K994182 | Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 with Fluoride | Pulpdent Corporation | LBH | Class II | |
| K993633 | Synthetic Vdrl Antigen | Centers for Disease Control and Prevention | GMQ | Class II | |
| K992290 | Exel Injection Plug with Cap | Exel Intl. | FPA | Class II | |
| K000365 | Accu-Chek Advantage Meter | Roche Diagnostics GmbH | CGA | Class II | |
| K000364 | Accu-Chek Complete Meter | Roche Diagnostics GmbH | LFR | Class II | |
| K000257 | Immulite 2000 Pap, Models L2kpa2, L2kpa6 | Siemens Healthcare Diagnostics Inc. | JFH | Class II | |
| K000210 | Modification to Model 5866-37M Lead Adaptor Kit | Medtronic, Inc. | DTD | Class II | |
| K000002 | Magna 5000 Phased Array Ctl Spine Coil | GE Healthcare Coils | MOS | Class II | |
| K994275 | Sims Portex Anesthesia Catheter | Abbott Medical | FRN | Class II | |
| K994228 | Remoteimage System | Etrauma.Com Corp. | LLZ | Class II | |
| K994021 | Contaclair Multi-Purpose Contact Lens Solution | Strieter Clinical Research Laboratories, Inc. | LYL | Class II | |
| K993990 | Leibinger Quik Disk Titanium Clamp System | Stryker Corp. | GXN | Class II | |
| K993979 | Marspo2, Model 2001 | Novametrix Medical Systems, Inc. | DQA | Class II | |
| K993976 | Pathway Vaginal Emg/stim Perineometer Sensor, Pathway Anal Emg/stim Perineometer Sensor | The Prometheus Group | KPI | Class II | |
| K993974 | Siemens Infinity Sc 6002Xl Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | MHX | Class II | |
| K992940 | Lemaitre Balloon Catheter with Irrigation | Vascutech, Inc. | DXE | Class II | |
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated | Bio-Vascular, Inc. | FTM | Class II | |
| K992461 | Stealthstation Treatment Guidance Platform | Surgical Navigation Technologies, Inc. | HAW | Class II | |
| K992214 | Oxycon Pro | Erich Jaeger, Inc. | BZC | Class II | |
| K991571 | 10 Curie Irdium 192, Csn00100-192 | Alpha Omega Services Inc | KXK | Class II | |
| K000228 | Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand | ArthroCare Corporation | GEI | Class II | |
| K000166 | Synthetic (White) Vinal Powdered Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | LYZ | Class I | |
| DEN990002 | Kavo Diagnodent | Kavo America | NBL | Class II | |
| K994424 | Diamedix Is-Anti-Dsdna Test System | Diamedix Corp. | LRM | Class II | |
| K994379 | EU-Ttg Iga Elisa | Scimedx Corp. | MVM | Class II | |
| K994361 | Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six Well Tissue Culture Plate, Esp Well | Genesis Industries, Inc. | MQK | Class II | |
| K994298 | Frios Microsaw | Friadent GmbH | KMW | Class II | |
| K994244 | Convertors Surgical Gowns, Sterile | Medtronic, Inc. | FYA | Class II | |
| K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] | Smith & Nephew, Inc. | JDW | Class II | |
| K994122 | Bone Graft Washer, Model 9090114 - 9090118 | Danek Medical, Inc. | KWQ | Class II | |
| K994100 | Pacific Hemostasis Thromboplastin D | Pacific Hemostasis | GJS | Class II | |
| K994076 | Implex Hedrocel Ps Tibial Component, Model Hedrocel Posterior Stabilized Tibial Component 05-Xxx-Yyyyy | Implex Corp. | JWH | Class II | |
| K993966 | 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter | Arrow Intl., Inc. | DSP | Class II | |
| K993965 | Cryo-Hit | Galil Medical Ltd. | GEH | Class II | |
| K993951 | Spot Endoscopic Marker | Chek-Med Systems | NBG | Class II | |
| K992657 | Ibc Vrv, Model 1350 | International Biophysics Corp. | DWD | Class II | |
| K992539 | Percuguard | Digit-Pro | LZB | Class I | |
| K992445 | Med-Guard Surgeon's Gown | Kappler USA | FYA | Class II | |
| K992359 | Mrs-Titan | Rotec Medizintechnik GmbH | LZO | Class II | |
| K991345 | Asp-100, Model 2100 | Vitrolife Sweden AB | MQL | Class II | |
| K983943 | Microstrep Plus Panel, Levofloxacin | Dade Microscan, Inc. | JWY | Class II | |
| K000363 | Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test System | Zeus Scientific LLC | DDC | Class II | |
| K000362 | Modification to Zeus Scientific, Inc., Tpo Igg Elisa Test System | Zeus Scientific LLC | JZO | Class II | |
| K000360 | Rx G-Universal | Jeneric/Pentron, Inc. | EJT | Class II | |
| K000217 | Royal Shield Non-Sterile Purple (Pink/blue) Colored Powdered Latex Exam with Protein Labeling Claim [<200 Mcg or Less] W | Shield Gloves Manufacturer (M) Sdn Bhd | LYY | Class I | |
| K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316 | Siemens Healthcare Diagnostics Inc. | DDR | Class II | |
| K000174 | Action Af-1 Wheelchair | Invacare GmbH | IOR | Class I | |
| K000156 | Smart Shield Non-Sterile Powder-Free Peppermint Scented Green Latex Examination Gloves | Shield Gloves Manufacturer (M) Sdn Bhd | LYY | Class I | |
| K000132 | Allergen Immunocap, Models C74, E89, Ex2, Ex70, Ex71, Ex73, Fx8, Fx9, Fx10, Fx16, Fx73, I72, I75, I76, K71, K73, K81, K8 | Pharmacia & Upjohn Company LLC | DHB | Class II |