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 |
|---|---|---|---|---|---|
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K242437 | Smile Dx® | Cube Click, Inc. | MYN | Class II | |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot S.L. | DZE | Class II | |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co.,Ltd. | PTI | Class II | |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | NAY | Class II | |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Merz North America, Inc. | OHV | Class II | |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | Canon Medical Systems Corporation | IYN | Class II | |
| K242762 | Aesculap Aicon® Series Container System | Aesculap Inc | KCT | Class II | |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty Limited | NKG | Class II | |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | |
| K250763 | Reon | C.E.I.B.Med | EBF | Class II | |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific Inc. | OWQ | Class II | |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co.,Ltd. | GEX | Class II | |
| K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | EIH | Class II | |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | QPB | Class II | |
| K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K243509 | Archer PSI System | 3D-Side | QHE | Class II | |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty Limited | MBI | Class II | |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | LHN | Class II | |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd | NUH | Class II | |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | Acon Laboratories, Inc. | SCA | Class II | |
| K251425 | turbodent touch | Mectron S.p.A. | KOJ | Class II | |
| K251126 | SKOUT system | Iterative Health | QNP | Class II | |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips North America LLC | IYN | Class II | |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation | OBJ | Class II | |
| K250758 | Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. | ITI | Class II | |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | GEI | Class II | |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd | NUH | Class II | |
| K243812 | Volta AF-Xplorer | Volta Medical | DQK | Class II | |
| K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | QLY | Class II | |
| K243290 | Btl-785Mj | BTL Industries, Inc | NUW | Class II | |
| K243230 | Second Opinion® BLE | Pearl, Inc. | QIH | Class II | |
| K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd | NUC | Class II | |
| K242732 | Tristel OPH | Tristel Solutions, Ltd. | QWS | Class II | |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | FPA | Class II | |
| K242392 | Path Bgc | Crossroads Neurovascular | QJP | Class II | |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | POV | Class II | |
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | Diasys Diagnostic Systems GmbH | PTF | Class II | |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | DQA | Class II | |
| DEN240045 | Teal Wand | Teal Health, Inc. | SEP | Class II | |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | CBK | Class II | |
| K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | NKB | Class II | |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech LLC | LRK | Class II | |
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp | QIH | Class II | |
| K243824 | Preat Abutments | PREAT Corporation | NHA | Class II | |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co.,Ltd. | NVK | Class II | |
| K243419 | Altus Spine Navigation System | Altus Partners | OLO | Class II | |
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | Leltek Inc. | IYN | Class II |