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 |
|---|---|---|---|---|---|
| K252519 | CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co., Ltd. | GEX | Class II | |
| K252041 | Fibresolve (with PCCP) | Imvaria | QWO | Class II | |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion Oy | JEY | Class II | |
| K251391 | BrainsWay Deep TMS System | Brainsway Ltd. | OBP | Class II | |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | ITI | Class II | |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | NXC | Class II | |
| K250264 | SugarBug (1.x) | BENCH7, Inc | MYN | Class II | |
| K243131 | Triathlon Pro | Sigma Biomedical | NUH | Class II | |
| K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | NGX | Class II | |
| K253265 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K252845 | Venus Nova (FP-2001) | Venus Concept Inc. | GEI | Class II | |
| K252525 | AIO Breathe | Aiomega, LLC | LRK | Class II | |
| K252515 | Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co., Ltd. | GEX | Class II | |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal Dca | DMP Dental Industry S.A. | KLE | Class II | |
| K252418 | Catalyst F1x Shoulder System | CATALYST ORTHOSCIENCE Inc | KWS | Class II | |
| K252133 | Adaptix Ortho350 | Adaptix Limited | IZF | Class II | |
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis Inc | DXX | Class II | |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | HWC | Class II | |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | OXO | Class II | |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | HBE | Class II | |
| K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | HBL | Class II | |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | FOZ | Class II | |
| K252514 | Evac-MRI | Phasor Health, LLC | JXG | Class II | |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | OLO | Class II | |
| K250376 | ViVY | Viatherm Therapeutics, LLC | IMJ | Class II | |
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | MEH | Class II | |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. | GZL | Class II | |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products Inc. | FXX | Class II | |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp | GEI | Class II | |
| K252664 | GMReis Suture Anchors | GM dos Reis Industria e Comercio Ltda | MBI | Class II | |
| K251709 | MedCAD® AccuStride™ System | MedCAD | PBF | Class II | |
| K251410 | VXvue | Vieworks Co., Ltd. | LLZ | Class II | |
| K251303 | Tamburo Thulium Fiber Laser System | menovex Medical Technology (Shenzhen) Co., Ltd | GEX | Class II | |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co Ltd | IOR | Class I | |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K253448 | Sonosite MT Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | LRK | Class II | |
| K252671 | Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. | ITI | Class II | |
| K252484 | cobas HCV | Roche Molecular Systems Inc | MZP | Class II | |
| K252481 | cobas CMV | Roche Molecular Systems Inc | PAB | Class II | |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange MedTech Co., Ltd. | HRX | Class II | |
| K251626 | Midmark Dental Delivery System | Midmark Corp | EIA | Class I | |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | LLZ | Class II | |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems Inc. | IYE | Class II | |
| K250330 | 3mensio Workstation | PIE Medical Imaging B.V. | QIH | Class II |