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 |
|---|---|---|---|---|---|
| K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. | LZA | Class I | |
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | OWT | Class II | |
| K232082 | Expd 4343S | DRTECH Corporation | MQB | Class II | |
| K231990 | Apex Locator | Cefla S.C. | LQY | Unclassified | |
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer Inc | QKB | Class II | |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty Limited | MQP | Class II | |
| K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-589) | Body Trim Industrial Co., Ltd. | NFO | Class II | |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Corp. | HIH | Class II | |
| K233533 | NerveTape | Biocircuit Technologies | JXI | Class II | |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | IYO | Class II | |
| K233260 | Univers Revers CA Head and Adapter | Arthrex GmbH | HSD | Class II | |
| K233217 | Mimics Cardiac Planner | Materialise N.V. | LLZ | Class II | |
| K233134 | I.T.S. INS Proximal Femur Nail | I.T.S. GmbH | HSB | Class II | |
| K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | |
| K233040 | EMS/TENS Massager Device | Shenzhen Imdk Medical Technology Co., Ltd. | NUH | Class II | |
| K232674 | PainFreeze II | Nuance Medical, LLC | MLY | Unclassified | |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co.,Ltd. | HIH | Class II | |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | NEU | Class II | |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | ODC | Class II | |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | NDN | Class II | |
| K240072 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Luliang Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | |
| K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | PBF | Class II | |
| K234037 | CATS-L Tonometer™ Prism | Cats Tonometer, LLC | HKY | Class II | |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. | QEW | Class II | |
| K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | OLO | Class II | |
| K233631 | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | OBP | Class II | |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | QUH | Class II | |
| K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | FLL | Class II | |
| K232072 | Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18G | H.S. Hospital Service S.p.A. | GEI | Class II | |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies Ltd | DRT | Class II | |
| K231355 | Aurora | Ensodata, Inc. | MNR | Class II | |
| K240086 | Ion 3D | Surgentec LLC | MRW | Unclassified | |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | KNT | Class II | |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | EHD | Class II | |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.r.l. | FLE | Class II | |
| K233480 | Access SHBG | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K233476 | Z1 Hip System | Orchard Medical Development | LZO | Class II | |
| K233350 | SINC Support Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K233184 | T2Bacteria® Panel | T2biosystems, Inc. | QBX | Class II | |
| K233080 | HealthFLD | Nano-X AI Ltd. | JAK | Class II | |
| K233024 | Alma Harmony | Alma Lasers Ltd. | GEX | Class II | |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | IWB | Class II | |
| K232644 | neuro42 MRI System | Neuro42, Inc. | LNH | Class II | |
| K231913 | T-Fit | Techwin Co., Ltd. | OAT | Class II | |
| K231662 | Aid-U | Iaid | LLZ | Class II | |
| K231575 | Vecttor VT-300 | Artaflex, Inc. | LIH | Class II | |
| K231536 | eQUANT System | Avails Medical, Inc. | QZX | Class II | |
| K230839 | Concentriq Dx | Proscia, Inc. | PSY | Class II | |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | EOQ | Class II | |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | WONTECH Co., Ltd. | OAP | Class II |