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 |
|---|---|---|---|---|---|
| K082513 | Onetouch Vita Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K082221 | Raydose | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K082088 | Mako Surgical Corp. Patellofemoral Knee Implant System II | Mako Surgical Corp. | KRR | Class II | |
| K081436 | Invirostripe 3Ml, 5Ml, 10Ml Luer Lock Syringes | Inviro Medical Devices, Inc. | FMF | Class II | |
| K081023 | Evolis Total Knee System | Medacta International SA | JWH | Class II | |
| K082774 | Lanx Cervical Intervertebral Body Fusion Device | Lanx, Inc. | MAX | Class II | |
| K082768 | G-Bond Plus | GC America Inc. | KLE | Class II | |
| K082767 | Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | HKI | Class II | |
| K082576 | Xchf-T160 Videoscope | Olympus Medical Systems Corp. | FBN | Class II | |
| K082532 | Straumann Guided Instruments | Straumann USA, LLC | DZI | Class II | |
| K082514 | Tens/ems Combo, Ems, TENS | Medihightec Medical Co., Ltd. | GZJ | Class II | |
| K082417 | Glucocard 01-Mini Blood Glucose Monitoring System, Model 73110 | Arkray Factory USA, Inc. | CGA | Class II | |
| K082135 | Showcase | Trillium Technology, Inc | LLZ | Class II | |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | HTN | Class II | |
| K081791 | E-Z Clean Electrosurgical Electrode | Megadyne Medical Products, Inc | GEI | Class II | |
| K081404 | Spinal Integration Spinal-Eze Intraoperative Epidural Catheter Kit | Spinal Integration, LLC | BSO | Class II | |
| K081210 | Nipro Safetouch Huber Infustion Set | Nipro Medical Corporation | FPA | Class II | |
| K080877 | 1Ml Unitract Insulin Syringe 27G*1/2 , 1Ml Unitract Syringe 29G*1/2 | Unilife Medical Solutions Limited | MEG | Class II | |
| K080466 | Alcohol Pad | 122 Corporation | QBP | Class II | |
| K073645 | Simpler Mini Dental Implant: Sm 3002 2.5 X 10Mm, Sm 3003 2.5 X 13Mm, Sm 3004 2.5 X 15Mm | 659543 BC, Ltd. | DZE | Class II | |
| K082564 | Hyperq System | Biological Signal Processing, Ltd. | MWI | Class II | |
| K082174 | Y-Adapter | Asthmatx, Inc. | KTI | Class II | |
| K082006 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | FAE | Class II | |
| K080854 | Disposable Blood Pressure Cuff, Model Dc100 | Suntech Medical, Inc. | DXQ | Class II | |
| K080629 | Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags | Promedical Products Co., Ltd. | KKX | Class II | |
| K083014 | Atlas Speeder Head/cervical Coil, Model Mjah-137A | Toshiba America Medical Systems, In.C | MOS | Class II | |
| K082960 | Ge Xtreme Injector Option | GE Healthcare | JAK | Class II | |
| K082954 | Encage Bipolar RF Probe | Trod Medical SA | GEI | Class II | |
| K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | NKB | Class II | |
| K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | HCG | Class II | |
| K082687 | Collamend Fm Implant | C.R. Bard Inc | FTM | Class II | |
| K082640 | Virtue Ventral Urethral Elevation Sling System | MEDLINE INDUSTRIES, LP - Northfield | OTM | Class II | |
| K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500At | Cnsystem Medizintechnik AG | DXN | Class II | |
| K082545 | Straumann Nn Cares Titanium and Ceramic Abutments | Straumann USA, LLC | NHA | Class II | |
| K082458 | P3t Abdomen | Medrad, Inc. | JAK | Class II | |
| K082375 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics Corp | HTY | Class II | |
| K082370 | Powder Free Nitrile Examination Glove (Blue) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K082260 | Integra Cervical and Petra Plif Lumbar Cages | Calvary Spine, LLC | MAX | Class II | |
| K082199 | Spiralfuse Peripheral Infusion System | Bacchus Vascular, Inc. | QEY | Class II | |
| K081594 | Medline Powder-Free Nitrile Examination Glove with Aloe | MEDLINE INDUSTRIES, LP - Northfield | LZA | Class I | |
| K081475 | Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] | Medtronic Xomed, Inc. | HBE | Class II | |
| K081438 | Matracell Decellularized Pulmonary Artery Patch Allograft | LifeNet Health | DXZ | Class II | |
| K081408 | Ellipse Multiflex | Ellipse A/S | GEX | Class II | |
| K081348 | Tenodesis Cross Screw, Interference Screw, Suture Bead | Trimed Inc | MBI | Class II | |
| K081127 | Accin Total Knee System | Accelerated Innovation, LLC | JWH | Class II | |
| K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model Gm505c; Caresens Pop Meter, Model Gm505ea or Gm505eb | I-SENS, Inc. | NBW | Class II | |
| K080909 | Iconoscope Oncofish Her2 Test System, Model 2000 | Ikonisys, Inc. | NTH | Class II | |
| K080908 | Innercool Therapies, Inc., Rapidblue System | Innercool Therapies, Inc.- A Delaware Corporation | NCX | Class II | |
| K080906 | Cdb Clip | CDB Corporation | NJM | Class II | |
| K073309 | Abx Pentra Hba1c Wb, Calibrator, Control and Hemolysis Reagent | Horiba Abx | LCP | Class II |