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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K241916 | TearRepair Liquid Skin Protectant | OptMed, Inc | KMF | Class I | |
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | |
| K241536 | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | OUJ | Class II | |
| K241513 | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | OLX | Class II | |
| K241480 | Jbs-Lvo | JLK, Inc. | QAS | Class II | |
| K241447 | iCare ST500 (TA04) | Icare Finland Oy | HKY | Class II | |
| K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | OMB | Class II | |
| K240745 | ID Free Personal Lubricant | WESTRIDGE LABORATORIES, Inc | NUC | Class II | |
| K240369 | CAC (gated) Algorithm | Bunkerhill Health | JAK | Class II | |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | FLL | Class II | |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | MEDLINE INDUSTRIES, LP - Northfield | BTT | Class II | |
| K233446 | AMC Health CareConsole | Amc Health | MWI | Class II | |
| DEN240017 | ShortCut | PI-Cardia Ltd | SCZ | Class II | |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K241895 | Cannulated PsiFGuard | Spineguard, Inc. | SCY | Class II | |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical Inc. | NEY | Class II | |
| K241815 | Protean Fragment Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer GmbH | HSB | Class II | |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | CIRCA Scientific, Inc. | DXF | Class II | |
| K241341 | cryo-GO Vitrification Device | FUJIFILM Biosciences Inc. | MQK | Class II | |
| K241216 | myAir | ResMed Corp | BZD | Class II | |
| K241147 | Any-Com | Mediclus Co., Ltd | EBF | Class II | |
| K241101 | BioButton System | Biointellisense Inc. | DRG | Class II | |
| K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | GXP | Class II | |
| K240854 | Accelerate Arc System | Accelerate Diagnostics, Inc. | QNJ | Class II | |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | NEU | Class II | |
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC | MQV | Class II | |
| K242273 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | MQV | Class II | |
| K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) | Dongguan Quanding Medical Supplies Co., Ltd | GEI | Class II | |
| K242075 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra Inc. | QEW | Class II | |
| K241860 | Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited | GEX | Class II | |
| K241535 | Vybe RF II | ShenB Co., Ltd. | GEI | Class II | |
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | LI Medical Corporation Ltd. | HHK | Class II | |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | NEU | Class II | |
| K240041 | IVD CAPSULE PSP; abioSCOPE | Abionic SA | SCX | Class II | |
| K242292 | uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | QAS | Class II | |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | OCX | Class II | |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | GEH | Class II | |
| K240236 | Happy Ring Health Monitoring System | Happy Health | MWI | Class II | |
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | BZD | Class II | |
| K233807 | LumiVy™ Lumbar IBF System | VY Spine, LLC | MAX | Class II | |
| K241834 | IPL Hair Removal Device (BE932C, BE932D, BE932E) | Shenzhen Yang WO Electronic Co., Ltd | OHT | Class II | |
| K241570 | Unity Total Knee System | Corin USA | JWH | Class II | |
| K240243 | EConsole2 | DRTECH Corporation | LLZ | Class II | |
| K240013 | EchoGo Heart Failure (2.0) | Ultromics, Ltd. | QUO | Class II | |
| K242650 | zLOCK Lumbar Facet Fixation System | ZygoFix | MRW | Unclassified | |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze | NRY | Class II | |
| K242223 | SuperSonic HepaVu | Supersonic Imagine | IYN | Class II |