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 |
|---|---|---|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty, Ltd. | MQF | Class II | |
| K173294 | Magnesium | Abbott Medical | JGJ | Class I | |
| K173110 | Graftsite | Summit Medical, LLC | BSP | Class II | |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | FYD | Class II | |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | ESW | Class II | |
| K172430 | ArgenIS Titanium Abutments | The Argen Corporation | NHA | Class II | |
| K172209 | Aura Icp Monitoring System | Branchpoint Technologies, Inc. | GWM | Class II | |
| K181111 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K181042 | Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | DXK | Class II | |
| K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter | Meril Life Sciences Private Limited | LOX | Class II | |
| K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | PLA | Class II | |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K173931 | MindMotion(TM) GO | Mindmaze SA | LXJ | Class II | |
| K173832 | InTice™-C Porous Ti Cervical Interbody System | Xtant Medical Holdings, Inc. | ODP | Class II | |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | Medical Components, Inc. | MSD | Class II | |
| K173360 | Athena 190 | Medical Rehab Products, LLC | IOR | Class I | |
| K172894 | Infrared Thermometer | Shenzhen Jiacom Technology CO., Ltd. | FLL | Class II | |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connector | Abbott Medical | PWH | Class II | |
| K172524 | Zimmer Persona Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K172480 | icotec Interbody Cage System | Icotec AG | ODP | Class II | |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. | FIE | Class II | |
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | Allergan | QBR | Class II | |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K180901 | Low Dose CT Lung Cancer Screening Option | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co. Ltd. | LPL | Class II | |
| K180527 | Is3 | Hiossen, Inc. | EKX | Class I | |
| K180519 | HARRIER-SA™ Lumbar Interbody System | Choicespine, LP | OVD | Class II | |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | Additive Orthopaedics, LLC | HRS | Class II | |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | JAQ | Class II | |
| K181153 | ICEfx Cryoablation System | Galil Medical Ltd. | GEH | Class II | |
| K181003 | Vivix-S 1717V | Vieworks Co., Ltd. | MQB | Class II | |
| K180986 | XableCath Support Catheter Product Family | Xablecath, Inc. | DQY | Class II | |
| K180883 | 5D Viewer | Samsung Medison Co., Ltd. | LLZ | Class II | |
| K180687 | Reliance Lumber IBF System | Reliance Medical Systems, LLC | MAX | Class II | |
| K180624 | Guided Growth Plate System Plus | Orthofix SRL | OBT | Class II | |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza SpA | GXN | Class II | |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn Bhd | LZC | Class I | |
| K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | LED Technologies, Inc. | OHS | Class II | |
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | Penumbra Inc. | QEW | Class II | |
| K173940 | Astroid Planning App | .Decimal, Inc. | MUJ | Class II | |
| K171449 | Metacem | Meta Biomed Co., Ltd. | EMA | Class II | |
| K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | IYN | Class II | |
| K180686 | SeaSpine Daytona Small Stature Spinal System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics Ltd. | IYN | Class II | |
| K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | |
| K173576 | Pristina Serena | GE Healthcare | MUE | Class II | |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | Myco Medical Supplies Inc | FMI | Class II | |
| K172640 | Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. | NHA | Class II | |
| K180776 | Cytal Wound Particulate | ACell, Inc | KGN | Unclassified | |
| K180727 | LineUp | CurveBeam, LLC | JAK | Class II |