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 |
|---|---|---|---|---|---|
| K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | Cogentix Medical, Inc. | EOX | Class II | |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | FCG | Class II | |
| K180650 | Amsel Endo Occluder | Amsel Medical Corporation | FZP | Class II | |
| K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | Yeti Dentalprodukte GmbH | EIH | Class II | |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | ConMed Corporation | HRX | Class II | |
| K182653 | Voyant Maryland Fusion Device | Applied Medical Resources Corp | GEI | Class II | |
| K182604 | New Era | Step UP Skin Laser, LLC | GEX | Class II | |
| K182603 | Z6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package | Snap40, Ltd. | MSX | Class II | |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | United Consortium | NUC | Class II | |
| K182101 | Riptide Aspiration System (React 71 Catheter) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K182097 | React 71 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | |
| K181963 | ostaPek Interbody Fusion Cages | Coligne AG | MAX | Class II | |
| K181886 | VivaSight-DL System | Etview, Ltd. | CBI | Class II | |
| K181850 | Inversa Implants | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K181829 | Velofix TLIF Cage | CG MedTech Co., Ltd. | MAX | Class II | |
| K181497 | Hpm-6000Uf | BTL Industries, Inc | KPI | Class II | |
| K181434 | SporView Rapid Read Biological Indicator SteamPlus Test Pack | Crosstex/Spsmedical, A Division of Cantel Medical | FRC | Class II | |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare GmbH | IOR | Class I | |
| K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC | EBF | Class II | |
| K172602 | Miracu | Feeltech Co.,Ltd. | NEW | Class II | |
| K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Largan Medical Co., Ltd. | LPL | Class II | |
| K182598 | VersaLink™ Fixation System | Premia Spine Ltd. | NKB | Class II | |
| K182508 | Saxxony™ Posterior Cervical Thoracic System | Nexxt Spine LLC | NKG | Class II | |
| K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | KNT | Class II | |
| K181369 | Immucise Intradermal Injection System | Terumo Corp. | FMI | Class II | |
| K180478 | RectalPro 75 Endorectal Balloon | Qlrad International, Ltd. | PCT | Class II | |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd | DQA | Class II | |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K182808 | Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. | KWQ | Class II | |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd | PNR | Class II | |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | GXH | Class II | |
| K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | NFT | Class II | |
| K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical Inc. | KPS | Class II | |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | DQY | Class II | |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio, LLC | DYW | Class II | |
| K182195 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | OVD | Class II | |
| K182083 | Catalys Precision Laser System | Advanced Medical Optics, Inc. | OOE | Class II | |
| K181992 | Heat Pain Pro | Omron Healthcare Co., Ltd. | NUH | Class II | |
| K181890 | Brainlab Compatible K2M Navigation Instruments | K2M, Inc | OLO | Class II | |
| K181759 | PowerDot PD-01MT | Smartmissimo Technologies Pte, Ltd. | IPF | Class II | |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Inc. | PDQ | Class II | |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | MQK | Class II | |
| K180966 | FilmArray Pneumonia Panel | BioFire Diagnostics, LLC | QDP | Class II | |
| K180395 | EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FMI | Class II | |
| K172907 | ELAN 4 Air Motor System | Aesculap Inc | HBB | Class II | |
| K182838 | Geistlich Derma-Gide | Geistlich Pharma AG | KGN | Unclassified | |
| K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | PMN | Class II | |
| K182462 | Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. | LZO | Class II |