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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143361 | Mammo Workstation | GE Healthcare | LLZ | Class II | |
| K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Medtronic, Inc. | DQA | Class II | |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture | Ethicon, Inc | GAM | Class II | |
| K142449 | Headway 27 Microcatheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K142294 | FlexiMarc Marker | Cortex Manufacturing, LLC | IYE | Class II | |
| K141961 | Genadyne Spiro Foam Dressing Kit | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K141847 | Avance Foam Dressing Kits | Molnlycke Health Care, US LLC | OMP | Class II | |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | OQY | Class II | |
| K150503 | Echo Bi-Metric Microplasty Line Extension | Zimmer GmbH | LPH | Class II | |
| K143533 | Fibergraft Bg Putty Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | Cayenne Medical Inc. | MBI | Class II | |
| K143443 | VEGA Knee System, Columbus Total Knee System | Aesculap Implants Systems, LLC | JWH | Class II | |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co KG | EBF | Class II | |
| K143083 | Bio-Medicus Pediatric Cannula and Introducers | Medtronic, Inc. | DWF | Class II | |
| K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface | Medtronic, Inc. | DTZ | Class II | |
| K143014 | F5 | Permobil, AB | ITI | Class II | |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | LXB | Class II | |
| K142892 | Powder-free Clear Vinyl Patient Examination Gloves | Shenyi Shandong Plastic Products Co Ltd | LYZ | Class I | |
| K142798 | PASS LP Spinal System | Medicrea International | MNH | Class II | |
| K142706 | Modified ONFLEX Mesh | C.R. Bard Inc | FTL | Class II | |
| K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II | |
| K141833 | Stylet, 23Cm, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-Go Pointer, Navigation | Medtronic Navigation, Inc | HAW | Class II | |
| K141715 | Glove Port | Nelis | GCJ | Class II | |
| K140213 | Disposable Endoscopic Cannula | Dongguan Microview Medical Technology Co., Ltd. | HGH | Class II | |
| K150368 | Tarsa-Link Wedge Fixation System | Life Spine | HRS | Class II | |
| K150193 | Customer Remote Console (CRC) | GE Healthcare | LLZ | Class II | |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health | FXX | Class II | |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | LZO | Class II | |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health | BXN | Class II | |
| K142649 | Progressive Orthopedic Total Knee System | The Progressive Orthopaedic Company, LLC | JWH | Class II | |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories Inc. | PDJ | Class II | |
| K141278 | Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | PGN | Class II | |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | NQW | Class II | |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | Synthes (USA) Products LLC | HRS | Class II | |
| K143207 | Revitive IX (OTC) | Actegy Ltd. | NGX | Class II | |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker Corp. | FWP | Class II | |
| K142776 | Flow-Screw | Flow-Fx, LLC | HWC | Class II | |
| K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | CBP | Class II | |
| K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | NYN | Class II | |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) | Terumobct, Inc. | LKN | Unclassified | |
| K140954 | Luofucon Silver Pu Antibacterial Foam Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K140806 | Ibs Implant System | Innobiosurg Co., Ltd. | DZE | Class II | |
| K140477 | Biogel Ps Surgical Glove Series, Biogel Skinsense Surgical Glove Series | Molnlycke Health Care, US LLC | KGO | Class I | |
| K150449 | LITe Plate System | Stryker Corp. | KWQ | Class II | |
| K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | IYO | Class II | |
| K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | DWF | Class II | |
| K150410 | Restoris Porous Partial Knee System | Mako Surgical Corp. | HRY | Class II | |
| K143668 | Navio | Blue Belt Technologies, Inc. | OLO | Class II | |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | Zimmer Spine, Inc. | KWQ | Class II | |
| K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | HIF | Class II |