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 |
|---|---|---|---|---|---|
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd | INI | Class II | |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | EZD | Class II | |
| K253888 | MOLLI 2 System | Stryker Corp. | NEU | Class II | |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd | NUH | Class II | |
| K252951 | Genesis Sleep | Neurofield, Inc. | QJQ | Class II | |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical | HWC | Class II | |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | DXC | Class II | |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex GmbH | MBI | Class II | |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | KPS | Class II | |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical Inc. | QIH | Class II | |
| K251091 | Lipids | Truvian Health | CHH | Class I | |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare, LLC | FLE | Class II | |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | Techno-Path Manufacturing Ltd. | QCH | Class II | |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | |
| K253343 | Celebrace Software | Celebrace | PNN | Class II | |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions, Inc | HTY | Class II | |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co. Ltd | CAW | Class II | |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT | Medtronic, Inc. | JOH | Class II | |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | FGE | Class II | |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Medtronic, Inc. | BZT | Class II | |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | OHS | Class II | |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | OAP | Class II | |
| K253342 | Pico-K | Speclipse, Inc. | GEX | Class II | |
| K253279 | Feather/numiere 05 06 07 (05) | Heat in a Click LLC | OHS | Class II | |
| K254163 | VarioSurg 4 | Nakanishi Inc. | DZI | Class II | |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | OHT | Class II | |
| K253740 | Tens&ems (Hz9151b, Hz9151c, Hz9151d) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | KWL | Class II | |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific LLC | NGL | Class II | |
| K253341 | Custom Abutments AS | Medentika GmbH | NHA | Class II | |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | NHA | Class II | |
| K253281 | UpDoc | Updoc | NDC | Class II | |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty Limited | MBH | Class II | |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | HRX | Class II | |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | OHS | Class II | |
| K253122 | Sim&Size | Sim&cure | PZO | Class II | |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea SAS | MUJ | Class II | |
| K253072 | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | Linhejiacheng (Shenzhen) e-Commerce Co., Ltd. | HGX | Class II | |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | |
| K252633 | Unity Dx (Udx) | Cylite Pty., Ltd. | OBO | Class II | |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical | DHB | Class II | |
| K252379 | AIR Recon DL | GE Healthcare | LNH | Class II | |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | NFO | Class II | |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | NFO | Class II | |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | DZE | Class II | |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | JOJ | Class II | |
| K251978 | Liaison Nes Flu A/b, Rsv & Covid-19 | DiaSorin Molecular LLC | QOF | Class II | |
| K251958 | VEINOPLUS Back | Dynapulse Medical LLC | NUH | Class II | |
| K251800 | Healgen® URS Test Strips | Healgen Scientific LLC | JMT | Class I | |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | LPL | Class II |