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 |
|---|---|---|---|---|---|
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics Inc. | CGX | Class II | |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | NEZ | Class II | |
| K242395 | Nanox.ARC | Nano-X Imaging Ltd | IZF | Class II | |
| K242348 | Locking Screw,CoCrMo | Double Medical Technology Inc. | HWC | Class II | |
| K242301 | Socrates 38 Catheter | Scientia Vascular | QJP | Class II | |
| K242185 | Rextar Pro | Raypia Co., Ltd. | EHD | Class II | |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories | MPA | Class II | |
| K241197 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | |
| K240671 | XBeam (v2) | Xstrahl Limited | MUJ | Class II | |
| K243470 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | MBI | Class II | |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | GEH | Class II | |
| K242861 | TrueLok Elevate | Orthofix SRL | KTT | Class II | |
| K242188 | ClearRead CT CAC | Riverain Technologies | JAK | Class II | |
| K241486 | Sofsilk™ Coated Braided Silk Suture | Medtronic, Inc. | GAP | Class II | |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | FEB | Class II | |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | JCX | Class II | |
| K243232 | GripMate | Synthon Hispania S.L. | KZH | Class II | |
| K243020 | MIDASVu | Intravu, Inc. | HRX | Class II | |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | OAP | Class II | |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | |
| K240475 | Hintermann Series H2 Total Ankle System | Vilex LLC | HSN | Class II | |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations Ltd. | CBK | Class II | |
| K243375 | Ruthless Spine RJB | Ruthless LLC dba Ruthless Spine | QWL | Class II | |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Medline ReNewal | NLH | Class II | |
| K241628 | YO Home Sperm Test | Medical Electronic Systems Ltd. | POV | Class II | |
| K241090 | Evie Med Ring | Movano Inc. dba Movano Health | DQA | Class II | |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & Co. KG | FBO | Class II | |
| K243408 | TACTIX Vector Syndesmosis System | Vilex LLC | HTN | Class II | |
| K243362 | SmoothSkin Pure Switch (SSC1) | Cyden Limited | OHT | Class II | |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. | JFB | Class II | |
| K243354 | Remunity System | Deka Research & Development Corp. | QJY | Class II | |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | PGY | Class II | |
| K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating LLC | OHS | Class II | |
| K242638 | LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. | OHS | Class II | |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K242308 | Power wheelchair | Zhejiang Zhonglei Medical Technology Co., Ltd. | ITI | Class II | |
| K242187 | BioBrace® | ConMed Corporation | OWW | Class II | |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | KPI | Class II | |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | QPB | Class II | |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | PTI | Class II | |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Spectrum Vascular | FOZ | Class II | |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd | QAU | Class II | |
| K240645 | Sonix Health | Ontact Health Co., Ltd. | QIH | Class II | |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | EBF | Class II | |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | CIRCA Scientific, Inc. | DXF | Class II | |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | OVD | Class II | |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | DXN | Class II | |
| K243050 | TriMed Posterior Malleolus Fixation System | Trimed Inc | HRS | Class II | |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II |