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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190628 | FlexSeal Introducer Sheath with Hydrophilic Coating | Freudenberg Medical Mis, Inc. | DYB | Class II | |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic, Inc. | OCL | Class II | |
| K190160 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | LFL | Unclassified | |
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | EmCyte Corporation | JQC | Class I | |
| K182660 | GaltTWS | Galt Medical Corp | DRB | Class II | |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems, B.V. | QHA | Class II | |
| K182308 | Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. | LZA | Class I | |
| K173158 | Air Relax | Maxstar Industrial Co Ltd | IRP | Class II | |
| K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K191124 | Swiss LithoClast Trilogy | E.M.S. - Electro Medical Systems SA | FFK | Class II | |
| K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M ESPE Dental Products | EMA | Class II | |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | OVD | Class II | |
| K190534 | Manual Wheelchair SIVFH2A102 | Jiangsu Horizon Medical Science & Technology Co., Ltd. | IOR | Class I | |
| K190510 | GuttaSil | Meta Biomed Co., Ltd. | KIF | Class II | |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott Medical | DRA | Class II | |
| K183645 | Silver High Performance Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch Pharmazeutische Fabrik GmbH | EBG | Class II | |
| K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical Inc. | KNT | Class II | |
| K183084 | Fuji Cervical Plate System | Altus Partners | KWQ | Class II | |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | ESW | Class II | |
| K182716 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | JAK | Class II | |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited | KNG | Class II | |
| K182403 | Peel-Away Introducer | Cook Incorporated | FED | Class II | |
| K181630 | Revolution External Plating System | New Standard Device dba Metalogix | KTT | Class II | |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group Ltd. | CFN | Class II | |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | |
| K190482 | IGNITE Bone Void Filler | Wrightmedicaltechnologyinc | MQV | Class II | |
| K190474 | MectaLock PEEK Suture Anchor | Medacta International SA | MBI | Class II | |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | Nihon Kohden Corp. | MWI | Class II | |
| K182544 | AccelFix Spinal Fixation System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K180739 | Clearlink System Solution Set | Baxter Healthcare Corporation | FPA | Class II | |
| K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | FXX | Class II | |
| K191083 | COMPLETE CONTROL System Gen2 | Coapt LLC | GXY | Class II | |
| K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | ITX | Class II | |
| K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | FAD | Class II | |
| K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | GEX | Class II | |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med (USA), Inc. | HQF | Class II | |
| K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | Bioncise NV | KNW | Class II | |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical Inc | DTQ | Class II | |
| K190231 | InCore® Lapidus Sterile Kits | Medartis AG | HWC | Class II | |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | Molnlycke Health Care, US LLC | KGO | Class I | |
| K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | ODW | Class II | |
| K182575 | Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Jiangxi Jaysun Medcare Co., Ltd. | LYZ | Class I | |
| K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | LZO | Class II | |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | KOD | Class II | |
| K181157 | Conical Plus Implant System | Osseofuse International Inc. | DZE | Class II | |
| K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | OVD | Class II | |
| K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | QEP | Class II | |
| K190469 | ERBEFLO 2 Disposable Tubing System | Erbe USA Inc | OCX | Class II |