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 |
|---|---|---|---|---|---|
| K241235 | Arthrex TightRope II | Arthrex GmbH | MBI | Class II | |
| K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) | Devoro Medical, Inc. | QEW | Class II | |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | QNQ | Class II | |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | NEY | Class II | |
| K240159 | InnoVoyce VYLO | InnoVoyce LLC | GEX | Class II | |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | KTT | Class II | |
| K233655 | Lingo Glucose System | Abbott Medical | SAF | Class II | |
| K233481 | AltiVate Reverse® Glenoid | Encore Medical, LP | PHX | Class II | |
| K233389 | EK Digital Abutments | Hiossen, Inc. | NHA | Class II | |
| K233166 | NET Recovery Corp/NET Device | Net Recovery Corp | PZR | Class II | |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | QJI | Class II | |
| K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | PCH | Class II | |
| K241177 | React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | DQY | Class II | |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) | Theralaser Medtech (China) Co., Ltd. | GEX | Class II | |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix SRL | MAX | Class II | |
| K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Xingyu Medical Tech Co.,Ltd | LZA | Class I | |
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | MRN | Class II | |
| K240305 | ANNE Limb | Sibel Health Inc. | DQA | Class II | |
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd | KIF | Class II | |
| K233344 | Regenalase Laser System | IPG Medical Corporation | GEX | Class II | |
| K233076 | Laser Speckle Imaging System (RFLSI CZW) | RWD Life Science Co., Ltd. | DPT | Class II | |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | eResearchTechnology GmbH | BTY | Class II | |
| K241178 | DEKA ACE Pump System | Deka Research & Development Corp. | QFG | Class II | |
| K240864 | PacePro Wire | Opsens Inc. | DQX | Class II | |
| K240827 | Set-5002 | Shimadzu Corporation Medical Systems Division | KPS | Class II | |
| K240810 | Anti Grinding Guard | Xiamen Yizhou Imp. & EXP. Co., Ltd. | OBR | Unclassified | |
| K240769 | LVivo IQS | Dia Imaging Analysis, Ltd. | QIH | Class II | |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | KWQ | Class II | |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products Inc. | FRG | Class II | |
| K233386 | Monik™ - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | GCJ | Class II | |
| K233285 | KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. | NHA | Class II | |
| K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | Foshan United Medical Technologies Ltd. | FRO | Unclassified | |
| K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | HRS | Class II | |
| K232788 | Inspira Art100 | Inspira Technologies Oxy B.H.N., Ltd. | DWA | Class II | |
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | KHJ | Class II | |
| K232639 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | |
| K232632 | Racz Neurostat RF Generator | Epimed International, Inc. | GXD | Class II | |
| K231939 | Renasys Edge | Smith & Nephew Medical Ltd | OMP | Class II | |
| K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | DZE | Class II | |
| K241396 | uCerv Flux™-C 3D Porous Titanium Cervical Interbody | ulrich medical USA Inc | ODP | Class II | |
| K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | KCI USA, Inc. | OMP | Class II | |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | Brainlab, Inc. | OLO | Class II | |
| K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | LLZ | Class II | |
| K233868 | dima Print Teeth & Temp | Kulzer GmbH | EBG | Class II | |
| K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment Inc. | MRN | Class II | |
| K233120 | Cwm-930S, Fixer Dv9 | Chungwoo Co., Ltd. | GEI | Class II | |
| K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | QFM | Class II | |
| K232642 | AirKEE T900 | Healkee Medical Pte. Ltd. | FRA | Class II |