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 |
|---|---|---|---|---|---|
| K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | OBR | Unclassified | |
| K091527 | Advance 35Lp Low Profile Pta Balloon Dilatation Catheter | Cook Inc. | DQY | Class II | |
| K091432 | Xclose Tissue Repair System, Model Xc-200-01 | Anulex Technologies, Inc. | GAT | Class II | |
| K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions LLC | DQY | Class II | |
| K091181 | Lockbox for Use with Medfusion 3000 Series Pumps | Abbott Medical | MRZ | Class II | |
| K091020 | Bluephase 20I | Ivoclar Vivadent, Inc. | EBZ | Class II | |
| K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | Depuy Orthopaedics Inc. | JDI | Class II | |
| K090970 | Flocontrol , Model 1028 | Coaxia, Inc. | MJN | Class II | |
| K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (Cms-II) | Twin Star Medical, Inc. | LXC | Unclassified | |
| K090929 | Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for Single Use with Fixed Needle | Shanghai Double Dove Industrial Co., Ltd. | FMF | Class II | |
| K090660 | Airway Balloon Catheter Inflation Device | Acclarent Inc | KTI | Class II | |
| K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model Behmo70000,beq-Hmo70000 | MAQUET CARDIOPULMONARY GmbH | DTZ | Class II | |
| K090426 | Vaku-8 Blood Collection Needles | Myco Medical Supplies Inc | FMI | Class II | |
| K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser Nd: Yag Lasers | Patholase, Inc. | GEX | Class II | |
| K083449 | E-Matrix Graft Bone Extender | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K083352 | Veinwave, Tc3000 | Newlands Clinical Trials, Ltd. | ONQ | Class II | |
| K082505 | Kls Martin Electrosurgical Instruments | Kl Martin L.P. | GEI | Class II | |
| K082367 | Infant Sleep Beanie | Life Innovations, LLC | FRP | Class I | |
| K091490 | Family of Thd Disposable Anoscopes/proctoscopes/rectoscopes | Thd SpA | FER | Class II | |
| K091400 | Modification to Avie A1c Test System | Mec Dynamics Corp | LCP | Class II | |
| K090767 | Perpos Fcd-2 System (Single Patient Use), Anchor, Stabilizer | Interventional Spine, Inc. | MRW | Unclassified | |
| K090671 | Pulse Oximeter, Models Cms50e, Cms50f, Cms60c, Cms60d | Contec Medical System Co., Ltd. | DQA | Class II | |
| K090012 | Disposable Infusion Set | Shan Dong Wei Gao Group Medical Polymer Products | FPA | Class II | |
| K083687 | Baixin Intravascular Administration Set | Anhui Kangda Medical Products Co., Ltd. | FPA | Class II | |
| K091589 | Microlife Digital Electronic Thermometer, Model Mt16k1 | Microlife Intellectual Property GmbH | FLL | Class II | |
| K091505 | Cor12+ | Viasys Healthcare GmbH | DSH | Class II | |
| K091266 | Theken Coral Spinal System | Theken Companies LLC | NKB | Class II | |
| K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model Cs 21, Cs 25, Cs 28, Cs 32, Cs 21L, Cs 25L, Cs 28L, Cs 32L | Frankenman International Limited | GDW | Class II | |
| K090747 | Mi Flow (Gcuc-450) | GC America Inc. | EBF | Class II | |
| K090680 | Heparin Lock Flush Solution, Usp Bd Posiflush Heparin Lock Flush Syringe | Becton Dickinson & Co | NZW | Class II | |
| K090648 | Viper 2 System | DePuy Spine, Inc. | NKB | Class II | |
| K090399 | Trios System | Viora, Ltd. | ONF | Class II | |
| K090093 | Stanbio Laboratory Hemopoint H2 Dm Hemoglobin Measurement System | Stanbio Laboratory | GKR | Class II | |
| K083292 | Habib Endohpb | Emcision, Ltd. | KNS | Class II | |
| K083010 | Shenzhen Med-Linket Adult Finger Clip Spo2 Sensor, Shenzhen Med-Linket Adult Silicone Soft Tip Spo2 Sensor | Shenzhen Med-Link Electronics Tech Co.,Ltd | DQA | Class II | |
| K083008 | Coolskin | Elbio Co., Ltd. | ILO | Class II | |
| K091340 | Through the -Peg (Ttp) Jejunal Feeding Tube Kit, Model M00566320,m00566330, M00566340, M00566350 | Boston Scientific Corporation | FPD | Class II | |
| K090161 | Epiphany Injection System | Staar Surgical AG | MSS | Class I | |
| K090132 | Maxmorespine Spinal System | Hoogland Spine Products GmbH | HRX | Class II | |
| K083275 | Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 | Max Endoscopy, Inc. | KNS | Class II | |
| K091260 | Seraquest Ebv Ea-D Igg Test | Quest Intl., Inc. | LSE | Class I | |
| K090926 | Smith & Nephew Rail System | Smith & Nephew, Inc. | KTT | Class II | |
| K090698 | Capiox Bubble Trap with X-Coating | Terumo Cardiovascular Systems Corporation | KRL | Class II | |
| K090546 | Modification to Nordicice Software | Nordicimaginglab AS | LLZ | Class II | |
| K090298 | Nuvasive Neuro Vision System | NuVasive Inc | GWF | Class II | |
| K083716 | First Response Early Result Pregnancy Test (OTC) | Church & Dwight Co., Inc. | LCX | Class II | |
| K083669 | Obi | Euroteknika | DZE | Class II | |
| K091498 | Vitrea Endovascular Stent Planning Software | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K091395 | Mp5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | MHX | Class II | |
| K091370 | Radia Steerable Diagnostic Catheter | C.R. Bard Inc | DRF | Class II |