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 |
|---|---|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | ETA | Class II | |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | GXY | Class II | |
| K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | FBN | Class II | |
| K254066 | Etiometry Platform | Etiometry Inc. | PPW | Class II | |
| K254060 | Life Saving Tourniquet | TW Medical | DXC | Class II | |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | IYE | Class II | |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | PHX | Class II | |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&j Medical Equipment Co., Ltd. | ITI | Class II | |
| K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co.,Ltd | LQR | Class II | |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical | HWC | Class II | |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co.,Ltd. | HGX | Class II | |
| K252495 | Lssa (Np-200) | Newpong Co.,Ltd. | QPB | Class II | |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | |
| K250074 | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics | KWD | Class II | |
| DEN240071 | neuropacs | Automated Imaging Diagnostics, LLC | SHO | Class II | |
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. dba Consensus Orthopedics | HSX | Class II | |
| K260647 | Specchio | El.En S.p.A. | PBX | Class II | |
| K260184 | Onclarity™ Self-Collection Kit | Becton Dickinson & Co | SEP | Class II | |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics GmbH | NQD | Class II | |
| K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical Inc. | LOX | Class II | |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd | IYN | Class II | |
| K252246 | Leforte MMF System | Jeil Medical Corporation | JEY | Class II | |
| K252229 | Belliger Ace | Genoray Co., Ltd. | OWB | Class II | |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | GEH | Class II | |
| K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K252130 | LifeShield Infusion Safety Software Suite | Abbott Medical | PHC | Class II | |
| K252079 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | KPE | Class II | |
| K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co.,Ltd. | QBV | Class I | |
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co.,Ltd. | QBV | Class I | |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma SRL | NUC | Class II | |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen Hanhan Technology Co., Ltd | DXN | Class II | |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | QIH | Class II | |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc | HRS | Class II | |
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | HLZ | Class II | |
| K253582 | Medical Imaging Calibration Feature (MICF) | Apple Inc. | SHN | Class I | |
| K253473 | Synchrony | Stereotaxis Inc | DQK | Class II | |
| K253405 | Prana System | Prana Surgical | GEI | Class II | |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | ConvaTec Limited | EZD | Class II | |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited | FOZ | Class II | |
| K242303 | Mod-C | Orthomod, LLC | ODP | Class II | |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd | GEX | Class II | |
| K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co Ltd | IOR | Class I | |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | Vatech Co., Ltd. | OAS | Class II |