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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | KLE | Class II | |
| K170916 | Portable Nebulizer | Microbase Technology Corp. | CAF | Class II | |
| K170688 | PIT’Stop® implant | In2Bones SAS | HWC | Class II | |
| K170053 | Meridian PM | The Center for Craniofacial & Dental Sleep Medicine | LRK | Class II | |
| K161652 | Diazir | Zxtgy (Beijing) Technology Co., Ltd. | EIH | Class II | |
| K173135 | VariAx 2 System | Stryker Corp. | HWC | Class II | |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb Incorporated | MRC | Class II | |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics Corp. | MCW | Class II | |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. C/O Linda Braddon, PhD | GXQ | Class II | |
| K172300 | CoLink View Plating System | In2bones USA, LLC | HRS | Class II | |
| K172030 | Devon 51 | Devon Medical Products (Jiangsu) Ltd | JOW | Class II | |
| K171757 | Straumann Screw Retained Abutments | Straumann USA, LLC (on Behalf of Institut Straumann AG) | NHA | Class II | |
| K171488 | PSLT for PASCAL Streamline | Iridex Corporation | HQF | Class II | |
| K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | MAI | Class II | |
| K170811 | Single Use Retrieval Nitinol Basket V | Olympus Medical Systems Corp. | LQR | Class II | |
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | OLO | Class II | |
| K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K172678 | Thermoplastic Elastomer Examination (Tpe) Glove | Shen Wei (USA), Inc. | LZA | Class I | |
| K172497 | NuVasive AttraX Scaffold | Nu Vasive, Incorporated | MQV | Class II | |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | Scican Ltd. | KCT | Class II | |
| K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | GZL | Class II | |
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant | Skanray Technologies Private Limited | OXO | Class II | |
| K170578 | True Function Adjustable Herbst Appliances | True Function Laboratory Inc | LRK | Class II | |
| DEN170017 | FilmArray Respiratory Panel 2 plus (RP2plus) | BioFire Diagnostics, LLC | PZF | Class II | |
| K173183 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | DJG | Class II | |
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory Co. | DAP | Class II | |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | PLC | Class II | |
| K172822 | Azurion series R1.2 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K172695 | AIR Anterior Array, AIR Posterior Array | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems Inc | DZE | Class II | |
| K172569 | GenePOC CDiff | Genepoc, Inc. | OZN | Class II | |
| K172539 | CereTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | |
| K172462 | OrthAlign Plus System | OrthAlign, Inc. | OLO | Class II | |
| K172424 | Velofix™ SA Cervical Cage | CG MedTech Co., Ltd. | OVE | Class II | |
| K172398 | DENTCA DENTURE Teeth | Dentca, Inc. | PZY | Class II | |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | GBM | Class II | |
| K172229 | Gc85a | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | Crospon, Ltd. | PIE | Class II | |
| K172111 | Vevazz LED | Vevazz, LLC | OLI | Class II | |
| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | NTK | Class II | |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Spryson America Inc | GWN | Class II | |
| K170983 | Niox Vero | Circassia AB | MXA | Class II | |
| K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K170662 | Non Contact Infrared Forehead Thermometer | Intrinity Global Limited | FLL | Class II | |
| K173112 | LAP-iX | Sejong Medical Co., Ltd. | GEI | Class II | |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel | Galil Medical Ltd. | GEH | Class II | |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | ODP | Class II | |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K172924 | GentleCath Intermittent Urinary Catheter | ConvaTec Limited | KOD | Class II |