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 |
|---|---|---|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical LLC | ODP | Class II | |
| K243387 | GYDER® Hip System | Gyder Surgical Pty Ltd | OLO | Class II | |
| K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows | SAH | Class II | |
| K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | GEH | Class II | |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments Ltd | DZE | Class II | |
| K241915 | CareSuperb™ COVID-19 Antigen Home Test | Access Bio, Inc. | QYT | Class II | |
| K244027 | Sansa Hsat | Huxley Medical | MNR | Class II | |
| K244025 | Argo Knotless GENESYS Anchor | ConMed Corporation | MBI | Class II | |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab, Inc. | HAW | Class II | |
| K243501 | 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | FRC | Class II | |
| K243439 | Medical Monitor (27HS714S) | LG Electronics.Inc | GCJ | Class II | |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | Shenzhen Rainbow Technology Co.,Ltd | OHS | Class II | |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | LCO | Class II | |
| K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | SAQ | Class II | |
| K243229 | Bunkerhill AVC | Bunkerhill Health | JAK | Class II | |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co, Ltd. | GEX | Class II | |
| K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | KPS | Class II | |
| K231297 | Firstar Dental Unit | Firstar Dental Company | EIA | Class I | |
| K244023 | Magentiq-Colo (Me-Apds) | Magentiq Eye Ltd | QNP | Class II | |
| K243739 | AxCess® Expandable Interbody System | Elliquence LLC | MAX | Class II | |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro Inc. | HAW | Class II | |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd | KNW | Class II | |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd | KNW | Class II | |
| K241239 | OrganProtex HTK Solution | Bridge to Life Ltd | KDL | Class II | |
| K241232 | Galen™ Second Read™ | Ibex Medical Analytics, Ltd. | QPN | Class II | |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics GmbH | DFC | Class II | |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. | PBX | Class II | |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd | NHN | Class II | |
| K243668 | ProLift Pivot Expandable Spacer System | Life Spine | MAX | Class II | |
| K243624 | Acu-Sinch Knotless Mini | Acumed LLC | HTN | Class II | |
| K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc | EOQ | Class II | |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon, Inc. | QIH | Class II | |
| K242714 | Mobility Scooter (S-01); Mobility Scooter (S-02) | Zhejiang Seedream Medical Equipment Co., Ltd. | INI | Class II | |
| K241819 | CephNinja | Cyncronus, LLC | LLZ | Class II | |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. | DXN | Class II | |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | GXI | Class II | |
| K241234 | Ots 25-L (100-5) | Ots-Medical | MBI | Class II | |
| K241199 | Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd | LDF | Class II | |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Abbott Medical | LHI | Class II | |
| K243982 | Nicolet EDX | Medtronic, Inc. | GWF | Class II | |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | LPH | Class II | |
| K243976 | ZeroClear™ Bag Access (423100) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K243350 | Rapid Neuro3D | Ischemaview, Inc. | QIH | Class II | |
| K243139 | Reverso Pro System | Indiba S. A. U. | GEI | Class II | |
| K243008 | Arthrex NanoScope System | Arthrex GmbH | GCJ | Class II | |
| K242835 | Suture-TOOL System | Suturion AB | NEW | Class II | |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development LLC | OMB | Class II | |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | Hunan Endoso Life Technology Co., Ltd | FGB | Class II | |
| K241357 | XT3 System | BioDynamik | JDW | Class II |