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 |
|---|---|---|---|---|---|
| K221273 | Medical Face Mask (M001) | Xingyu Medical Tech Co.,Ltd | FXX | Class II | |
| K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd | FXX | Class II | |
| K221256 | Mg OSTEOINJECT | Bone Solutions, Inc. | MQV | Class II | |
| K221195 | OsteoProbe | Active Life Scientific, Inc. | QGQ | Class II | |
| K220670 | Magnum | Magnum Health and Safety Pvt Ltd | FXX | Class II | |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | MAX | Class II | |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co.,Ltd | DSA | Class II | |
| K213726 | PL-1 Skin Treatment System | Avava, Inc. | GEX | Class II | |
| K213577 | VenAir, Sequential Compression System | Apex Medical, Inc. | JOW | Class II | |
| K213478 | BD Pen Needle | Becton Dickinson & Co | FMI | Class II | |
| K211718 | Venus Cervical Plate System | Artfx Medical LLC | KWQ | Class II | |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | FRC | Class II | |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | PBF | Class II | |
| K221233 | Dt-703 | ECOTRON Co., Ltd. | EHD | Class II | |
| K220851 | Venue | GE Healthcare | IYN | Class II | |
| K220848 | Venue Fit | GE Healthcare | IYN | Class II | |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd | FDI | Class II | |
| K220309 | Wearable Breast Pump (Model S10) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | Medtronic, Inc. | GCJ | Class II | |
| K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode | Ningbo Shun YE Medical Company, Ltd. | GEI | Class II | |
| K210947 | Navident | ClaroNav Inc. | PLV | Class II | |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | PBK | Class II | |
| K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | HCI | Class II | |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | JOJ | Class II | |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | OZE | Class II | |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K220377 | Procedure Mask | Little Rapids Corporation | FXX | Class II | |
| K220300 | Otoplan | Cascination | QQE | Class II | |
| K214123 | T-FIX® 3DSI Joint Fusion System | Cutting Edge Spine | OUR | Class II | |
| K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | OAP | Class II | |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | IYE | Class II | |
| K213250 | Secret Duo | Ilooda Co,., Ltd. | GEX | Class II | |
| K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | NUP | Class II | |
| K212741 | Ezypor | Fci (France Chirurgie Instrumentation) SAS | HPZ | Class II | |
| K212043 | Traus Endo | Saeshin Precision Co., Ltd. | EKX | Class I | |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical Ltd. | DZE | Class II | |
| K200715 | RoughRider Aurora Manual Wheelchair | Roughrider America LLC | IOR | Class I | |
| K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | LLZ | Class II | |
| K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc | QEW | Class II | |
| K221188 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | PUL | Class II | |
| K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | IYN | Class II | |
| K220756 | Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K220732 | Mural Perinatal Surveillance | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K220514 | bite away neo | Mibetec GmbH | IRT | Class II | |
| K220497 | CoLumbo | Smart Soft Healthcare AD | QIH | Class II | |
| K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel Ltd. | MSQ | Class I | |
| K213612 | Sylfirm X | VIOL Co., Ltd. | GEI | Class II | |
| K213349 | Catalyst R1 Reverse Shoulder System | CATALYST ORTHOSCIENCE Inc | PHX | Class II | |
| K213338 | Core-Clip | Incore Co., Ltd. | PKL | Class II | |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | DRG | Class II |