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 |
|---|---|---|---|---|---|
| K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte., Ltd. | FPA | Class II | |
| K230100 | Scizer (Sc1-M410) | Classys Inc | OHV | Class II | |
| K230078 | TRAX® CR Total Knee System | Amplitude | JWH | Class II | |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | EBZ | Class II | |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | AtriCure, Inc. | PZX | Class II | |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd | NFT | Class II | |
| K233056 | EpiZact | Guidestar Medical Devices Inc. | FMF | Class II | |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | MBI | Class II | |
| K232532 | Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co.,Ltd | GEX | Class II | |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. | OLO | Class II | |
| K232176 | STELLAR Knee | Polarisar Inc | SBF | Class II | |
| K232076 | Fibercure | Lumendo AG | QNF | Class II | |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | JXI | Class II | |
| K230800 | Xvision-525, Horizon, Hi-300, Hi-500, Saturn-F Pf32, Saturn-F Pf40, Saturn-F Pf50 | Gemss Healthcare Co., Ltd. | KPR | Class II | |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical LLC | PIF | Class II | |
| K233502 | Tera Harz II | Graphy Inc. | EBF | Class II | |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL | Class II | |
| K232880 | Inzii Ripstop Redeployable Retrieval System | Applied Medical Resources Corp | GCJ | Class II | |
| K232730 | Aventus Thrombectomy System | Inquis Medical, Inc. | QEW | Class II | |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical Ltd | DTZ | Class II | |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | OQB | Class II | |
| K233320 | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | MXD | Class II | |
| K232321 | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | DRA | Class II | |
| K232318 | VICTORY™ Lumbar Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific Oy | JWY | Class II | |
| K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) | Edwards Lifesciences LLC | DQK | Class II | |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics Inc. | JWH | Class II | |
| K231868 | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | |
| K231629 | 091 Balloon Guide Catheter | Eosolutions, Corp. | DQY | Class II | |
| K231362 | OCS Heart Leukocyte Depleting Filter | Transmedics, Inc. | DTM | Class II | |
| K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical Ltd | PQM | Class II | |
| K231243 | Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. | DQA | Class II | |
| K231238 | Ultravision2™ System | Alesi Surgical Ltd | PQM | Class II | |
| K230814 | Vrnt | CognifiSense, Inc. | QRA | Class II | |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | MEDLINE INDUSTRIES, LP - Northfield | CAF | Class II | |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | TORNIER Inc. | HSB | Class II | |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical Ltd | KNS | Class II | |
| K230083 | Safira | Medovate Limited | FRN | Class II | |
| K232751 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Healthcare | IYN | Class II | |
| K231874 | AOT & T-L Abutment | TruAbutment Inc. | NHA | Class II | |
| K231836 | ClariVy™ Cervical IBF System | VY Spine, LLC | ODP | Class II | |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. | PLP | Class II | |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.r.l. | NDN | Class II | |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corp. | OBO | Class II | |
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | Zhonghong Pulin Medical Products Co.,Ltd. | LZA | Class I | |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.r.l. | PBX | Class II | |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | EMPATICA S.r.l. | MWI | Class II |