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 |
|---|---|---|---|---|---|
| K190844 | Akesis Galaxy | Akesis Inc. | IWB | Class II | |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | EBF | Class II | |
| K183347 | K3 | OSSTEM Implant Co., Ltd. | EIA | Class I | |
| K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | DYB | Class II | |
| K191617 | Syntec Tibial Nail System | Syntec Scientific Corp. | HSB | Class II | |
| K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | KWQ | Class II | |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. KG | DWP | Class II | |
| K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe | Top Corporation | FMF | Class II | |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | |
| K192071 | iNSitu Total Hip System | Theken Companies LLC | LPH | Class II | |
| K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences LLC | DXN | Class II | |
| K191786 | Cyclops™ Anterior Cervical Plate System | Degen Medical | KWQ | Class II | |
| K191732 | Sutter RaVoR Bipolar Electrodes | Sutter Medizintechnik GmbH | GEI | Class II | |
| K191664 | SelectFlex 072 Neurovascular Access System | Q'apel Medical, Inc. | DQY | Class II | |
| K191554 | LightWalker Laser System Family | Fotona d.o.o. | GEX | Class II | |
| K191547 | ReliefBand | ReliefBand Technologies | GZJ | Class II | |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc | FED | Class II | |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Horiba Abx SAS | CJE | Class II | |
| K190810 | OPERA, OPERA eco | Unimom.Co | HGX | Class II | |
| K190719 | Artemis Eye System | Penumbra Inc. | GWG | Class II | |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics, Inc. | CEW | Class II | |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Olympus Medical Systems Corp. | FET | Class II | |
| K183475 | T1-Cs, T1-C | OSSTEM Implant Co., Ltd. | OAS | Class II | |
| K183407 | Triton Cage | Medyssey USA | MAX | Class II | |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | IYN | Class II | |
| K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | IYN | Class II | |
| K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | KWQ | Class II | |
| K192054 | Endoskeleton TAS Plate | Titan Spine, LLC | OVD | Class II | |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | Geistlich Pharma AG | NPL | Class II | |
| K192036 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | FYD | Class II | |
| K191939 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | |
| K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | Nobel Biocare AB | KCT | Class II | |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery, Inc. | OCW | Class II | |
| K191319 | Dunamis Fixation Button System | Dunamis, LLC | MBI | Class II | |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | HIH | Class II | |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | Invacare GmbH | CAW | Class II | |
| K190744 | Endoeye Hd II (Wa50040a, Wa50042a, Wa50050a, Wa50052a) | Olympus Winter & Ibe GmbH | HET | Class II | |
| K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | POC | Class II | |
| K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | LRK | Class II | |
| K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences LLC | DQK | Class II | |
| K183605 | Spine & Trauma Navigation | Brainlab, Inc. | OLO | Class II | |
| K183489 | D2p | 3D Systems, Inc. | LLZ | Class II | |
| K182811 | gel-e Flex+ | Gel-E, Inc. | QSY | Unclassified | |
| K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | GMP Medicare Sdn Bhd(F25) | LZC | Class I | |
| K182219 | SGS Dental Implants System | S.G.S. International Ltd | DZE | Class II | |
| K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | NKB | Class II | |
| K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC. | HIF | Class II | |
| K191778 | Omnia Medical VBR | Omnia Medical | PLR | Class II |