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 |
|---|---|---|---|---|---|
| K203654 | Solevy Co. LLC Water-Based Personal Lubricant | Solevy Co. LLC | NUC | Class II | |
| K203644 | Solevy Co. LLC Silicone Based Personal Lubricant | Solevy Co. LLC | NUC | Class II | |
| K203495 | Arthrex SwiveLock Anchor | Arthrex GmbH | MAI | Class II | |
| K203473 | Sozo | Impedimed, Inc. | DSB | Class II | |
| K203469 | AI Segmentation | Varian Medical Systems, Inc. | MUJ | Class II | |
| K203421 | Triathlon AS-1 | ConforMIS, Inc. | OOG | Class II | |
| K202506 | Karma Powered Wheelchair | Karma Medical Products Ltd. | ITI | Class II | |
| K210600 | Molli | Molli Surgical, Inc. | NEU | Class II | |
| K210276 | Disposable Nitrile Gloves | Fujian Ercon Medical Management Co., Ltd. | LZA | Class I | |
| K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | OAP | Class II | |
| K203616 | Brainsway Deep (DTMS) System | Brainsway Ltd. | QMD | Class II | |
| K203517 | Saige-Q | Deephealth | QFM | Class II | |
| K203170 | Infrared Thermometer Models: DT-8806S, DT-8807S | Shenzhen Everbest Machinery Industry Co Ltd | FLL | Class II | |
| K202419 | BIOTECH Nitrile Examination Gloves | Tk Hitech Technology Co., Ltd. | LZA | Class I | |
| K202055 | Looper (Model: ZX-579S) | Heat in a Click LLC | OLP | Class II | |
| K201047 | Fusion Taper System | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K200978 | Electric Wheelchair (Model: S7110) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | |
| K200271 | rainbow CT | Dentium Co.,Ltd(ict Branch) | OAS | Class II | |
| K200270 | rainbow MCT | Dentium Co.,Ltd(ict Branch) | OAS | Class II | |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | KRA | Class II | |
| K210539 | CoreLink Midline Fixation System | Corelink, LLC | NKB | Class II | |
| K210338 | Edge Insulated Blade Electrode | Medtronic, Inc. | GEI | Class II | |
| K210235 | Verrata PLUS Pressure Guide Wire | Volcano Corporation | DQX | Class II | |
| K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC | DZE | Class II | |
| K203364 | Mdpc-8127 | Barco N.V. | PSY | Class II | |
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | KWS | Class II | |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | |
| K202830 | Axiostat Patch | Advamedica Inc. | QSY | Unclassified | |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | TTK Healthcare Limited | HIS | Class II | |
| K201718 | GD Disposable Medical Face Mask | Jiangsu Guangda Medical Material Group Co., Ltd. | FXX | Class II | |
| K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies,Inc | HWC | Class II | |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products Inc | NEU | Class II | |
| K210493 | Cx30n (Cx30pqx) | Wide Corporation | PGY | Class II | |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Inc. | CBK | Class II | |
| K203390 | Artimes pro Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | LOX | Class II | |
| K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical Ltd. | QFM | Class II | |
| K202617 | Metapex Plus | Meta Biomed Co., Ltd. | KIF | Class II | |
| K201138 | AMSure® Single Use Saline Topical Solution | Amsino Medical Inc. | FRO | Unclassified | |
| K201127 | DEFEND Ear-loop Face Masks | Young Dental Manufacturing Co 1, LLC. | FXX | Class II | |
| K210764 | Flyte | Pelvital USA, Inc. | HIR | Class II | |
| K210658 | Volition Plating System | Ortho Solutions Inc | HRS | Class II | |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | HKI | Class II | |
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes | Stryker Corp. | GCJ | Class II | |
| K203500 | RetCam Envision | Natus Medical Incorporated | HKI | Class II | |
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | ELC | Class II | |
| K202884 | SR-1 Skin Treatment System | Avava, Inc. | ONG | Class II | |
| K202136 | IDS Cortisol | Immunodiagnostic Systems Ltd. | CGR | Class II | |
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | OWB | Class II | |
| K210629 | SecurAcath | Interrad Medical Inc | OKC | Class II | |
| K210456 | Ligament Staple | Medacta International SA | JDR | Class II |