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 |
|---|---|---|---|---|---|
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | GCJ | Class II | |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | OLO | Class II | |
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | BTA | Class II | |
| K252833 | VIVA combo RF System | Starmed Co.,Ltd | GEI | Class II | |
| K252797 | JAZBI™ Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | MQV | Class II | |
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | HRX | Class II | |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | GCJ | Class II | |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd | NFT | Class II | |
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB | KOI | Class II | |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | OBP | Class II | |
| K260329 | Ion-C Navigation Instruments | Surgentec LLC | OLO | Class II | |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | QIH | Class II | |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik a/S | OBP | Class II | |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd | DQX | Class II | |
| K254129 | Spectrum-2 | Neko Health AB | MUD | Class II | |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | IYN | Class II | |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong | Taizhou Huangyan Guanhong Plastic Steel Products Factory | MMK | Class II | |
| K253569 | Atmo Gas Capsule System | Atmo Biosciences Ltd | NYV | Class II | |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular Scitech Limited | QJP | Class II | |
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Co., Ltd. | KGO | Class I | |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee BioMedical, Inc. | PZX | Class II | |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | DQD | Class II | |
| K252887 | DePuy ATTUNE™ Knee System | Depuy Orthopaedics Inc. | OIY | Class II | |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | MUJ | Class II | |
| K252772 | Arc Adjustable Radial Cuff Compression Device | TZ Medical Inc. | DXC | Class II | |
| K252735 | C-beam | Pulmera, Inc. | OWB | Class II | |
| DEN250057 | PCWP Analysis Software | Cardiosense, Inc. | SIF | Class II | |
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | SAF | Class II | |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical, LLC | OMP | Class II | |
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | KNS | Class II | |
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH | FAJ | Class II | |
| K260618 | Ulthera® System | Merz North America, Inc. | OHV | Class II | |
| K260582 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | PKL | Class II | |
| K260234 | MSK Go | Smart Alfa Teknoloji San. ve Tic. A.S. | QIH | Class II | |
| K260068 | pjur NATURE Touch, 100 ml | pjur group Luxembourg S.A. | NUC | Class II | |
| K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | QME | Class II | |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co.,Ltd | IOR | Class I | |
| K254131 | Bac | Deephealth | QIH | Class II | |
| K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | FTL | Class II | |
| K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | OLR | Unclassified | |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd. | IYN | Class II | |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics Inc | GEX | Class II | |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | EIH | Class II |