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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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

176,415 records, page 584 of 3529

510(k) clearances, page 584 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163316	Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System	CareFusion 303, Inc	DSA	Class II	2017-06-22
K162723	TransFix/EDTA Vacuum Blood Collection Tubes	Caltag Medsystems Ltd	GIM	Class II	2017-06-22
K162299	Spiral Shape Dental Implant System	GP Implants Ltd	DZE	Class II	2017-06-22
K160899	CoVa Monitoring System 2	Tosense, Inc.	MWI	Class II	2017-06-22
K171485	BSD4343R Digital Flat Panel X-ray Detector	Bontech Co., Ltd	MQB	Class II	2017-06-21
K170864	VALIDATE D-Dimer Calibration Verification / Linearity Test Kit	Maine Standards Co.	GGN	Class II	2017-06-21
K170755	DRX-Revolution Nano Mobile X-ray System	Eastman Kodak Company	IZL	Class II	2017-06-21
K170714	Venue	GE Healthcare	IYN	Class II	2017-06-21
K170638	Retina Workplace	Carl Zeiss Meditec Inc	NFJ	Class II	2017-06-21
K170551	ImPACT Quick Test	Impact Applications, Inc.	POM	Class II	2017-06-21
K170016	Biodesign Fistula Plug	Cook Biotech Incorporated	FTM	Class II	2017-06-21
K163345	TVC Imaging System, TVC Catheter	Nipro Vascular Innovations Americas, Inc.	OGZ	Class II	2017-06-21
K163195	Primus	Carl Zeiss Suzhou Co., Ltd.	OBO	Class II	2017-06-21
K163104	Terrace™ Anterior Cervical Plate System	Corelink, LLC	KWQ	Class II	2017-06-21
K163049	GOLNIT Non-Absorbable PTFE Surgical Suture	Antarma dba Golnit Sutures	NBY	Class II	2017-06-21
K162737	VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)	bioMerieux, Inc.	LON	Class II	2017-06-21
K161808	Solution Set with 1.2 Micron Air Eliminating Filter	Baxter Healthcare Corporation	FPA	Class II	2017-06-21
DEN160040	Embosphere Microspheres	Biosphere Medical, S.A.	NOY	Class II	2017-06-21
K170918	Compex Sport Elite	DJO, LLC	NGX	Class II	2017-06-20
K170571	Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw	Tyber Medical	HWC	Class II	2017-06-20
K170418	Stryker SonicPin System	Stryker Trauma GmbH	HTY	Class II	2017-06-20
K170039	STERRAD VELOCITY Biological Indictator and Reader	Advanced Sterilization Products (Asp)	FRC	Class II	2017-06-20
K163593	Additive Orthopaedics Bunion System	Additive Orthopaedics, LLC	HRS	Class II	2017-06-20
K163494	Summit Spine Channel Cervical Interbody Fusion System	Summit Spine	ODP	Class II	2017-06-20
K163447	Premium Plus Disposable Barrier Sleeve	Premium Plus International Limited	PEM	Class II	2017-06-20
K162942	Corin MetaFix Hip Stem	Corin USA	LZO	Class II	2017-06-20
K162515	COSMED K5 Wearable Metabolic Technology	Cosmed S.r.l.	BZC	Class II	2017-06-20
K170903	Compex Wireless USA	DJO, LLC	NGX	Class II	2017-06-19
K170893	Materialise Glenoid Positioning System	Materialise N.V.	KWS	Class II	2017-06-19
K170693	Phantom Small Bone Intramedullary Nail System	Paragon 28	KTW	Class II	2017-06-19
K170669	Insulia Diabetes Management Companion	Voluntis	NDC	Class II	2017-06-19
K163506	Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System	Vertera, Inc.	MAX	Class II	2017-06-19
K163029	Hydris™ Oral Rinse	Biopharm Consult, LLC	LFD	Unclassified	2017-06-19
K162886	Deka Motus Ax	El.en. Electronic Engineering SpA	GEX	Class II	2017-06-19
K162788	ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA	Immco Diagnostics, Inc.	MSV	Class II	2017-06-19
K162641	Smith & Nephew, Inc. R3™ Constrained Liner	Smith & Nephew, Inc.	KWZ	Class II	2017-06-19
K162588	Möller Medical Biopsy Needles and Systems	Moller Medical GmbH	KNW	Class II	2017-06-19
K171538	Cure™ Lumbar Plate System	Meditech Spine, LLC	KWQ	Class II	2017-06-16
K171481	MagVita TMS Therapy System	Tonica Elektronik a/S	OBP	Class II	2017-06-16
K171223	Quantum TTC Biliary Balloon Dilator	Wilson-Cook Medical Inc.	FGE	Class II	2017-06-16
K170909	Infinix INFX-8000V, V6.40	Toshiba Medical Systems Coroporation	OWB	Class II	2017-06-16
K170843	Alians Fragment Specific	Newclip Technics	HRS	Class II	2017-06-16
K170474	Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter	Innovative Health, LLC.	OWQ	Class II	2017-06-16
K170191	SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System	Medtronic, Inc.	MCW	Class II	2017-06-16
K170066	Green16/Green18 (Model: PHT-65LHS)	Vatech Co., Ltd.	OAS	Class II	2017-06-16
K163676	Silhouette InstaLift	Sinclair Pharma US, Inc.	GAM	Class II	2017-06-16
K162674	BioPro Foot Plating Systems	Biopro, Inc.	HRS	Class II	2017-06-16
K162659	Diode Laser Hair Removal System	Shandong Huamei Technology Co.,Ltd.	GEX	Class II	2017-06-16
K162215	Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae	Corcym Inc.	DWF	Class II	2017-06-16
K161582	DORA Tubing Sets for Hemodialysis	Bain Medical Equipment(guangzhou) Co., Ltd.	FJK	Class II	2017-06-16