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 618 of 3529

510(k) clearances, page 618 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160785	Worker Guidewire	Argon Medical Devices, Inc	DQX	Class II	2016-12-08
K163115	Gc70	Samsung Electronics Co., Ltd.	KPR	Class II	2016-12-07
K163034	SUTUREFIX Curved Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2016-12-07
K161322	CT CoPilot	Zepmed, LLC	LLZ	Class II	2016-12-07
K161244	s-Clean OneQ-SL Narrow Implant System	Dentis Co.,Ltd	DZE	Class II	2016-12-07
K160222	OIC Cervical PEEK Spacer	The Orthopaedic Implant Company	ODP	Class II	2016-12-07
K160070	Rheumatoid Factor (RF) Kit for use on SPAPLUS	The Binding Site Group Ltd.	DHR	Class II	2016-12-07
K163105	Emprint Ablation System	Medtronic, Inc.	NEY	Class II	2016-12-06
K162896	Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface	Medtronic, Inc.	DTZ	Class II	2016-12-06
K162428	DiLumen Endolumenal Interventional Platform	Lumendi, LLC	FDF	Class II	2016-12-06
K162304	Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets	Quest Medical, Inc	FPA	Class II	2016-12-06
K161809	ShurFit CpTi-HA ACIF Interbody Fusion System	Precision Spine, Inc.	ODP	Class II	2016-12-06
K161800	OnSite-IV	Pharmc, LLC	LHI	Class II	2016-12-06
K161769	Reprocessed Supreme Diagnostic Electrophysiology Catheters	Innovative Health, LLC.	DRF	Class II	2016-12-06
K161702	Endura guidewire	Vascular Solutions LLC	DQX	Class II	2016-12-06
K160811	Crw Stereotactic System	Integra LifeSciences Corporation	HAW	Class II	2016-12-06
K160695	Talymed Suspension	Marine Polymer Technologies, Inc.	FRO	Unclassified	2016-12-06
K160492	Hospira Sapphire Sets	Abbott Medical	MRZ	Class II	2016-12-06
K163222	Discovery Pico Family	Quanta System Inc.	GEX	Class II	2016-12-05
K163098	Tri-Staple 2.0 Intelligent Cartridge	Medtronic, Inc.	GDW	Class II	2016-12-05
K162127	Bencox M Stem Lateralized & Bencox Mirabo Cup System	Corentec Co., Ltd.	LPH	Class II	2016-12-05
K162048	EZstim*III Peripheral Nerve Stimulator/Nerve Locator	Halyard Health - Irvine	KOI	Class II	2016-12-05
K162004	PREMIUM Implant Systems SHELTA Implant Systems	Sweden & Martina Inc	NHA	Class II	2016-12-05
K161757	Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads	Victor Medical Instruments Co., Ltd	GDW	Class II	2016-12-05
K161728	Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1	Microfile Intellectual Property GmbH	FLL	Class II	2016-12-05
K161453	WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A	Well-Life Healthcare Limited	NUH	Class II	2016-12-05
K161425	APEX Manual Wheelchair	Motion Composites	IOR	Class I	2016-12-05
K160946	4.0 and 6.5 Cancellous Bone Screw and Washer	Smv Scientific	HWC	Class II	2016-12-05
K153015	Transfer & Angled Abutment	OSSTEM Implant Co., Ltd.	NHA	Class II	2016-12-05
K152009	DENSEEMAMMO v1.0	Statlife	LLZ	Class II	2016-12-05
K163158	MEDSYNAPSE Zero Footprint Viewer	Medsynaptic Private Ltd.	LLZ	Class II	2016-12-02
K162972	ExactVu High Resolution Micro-Ultrasound System	Exact Imaging, Inc.	IYO	Class II	2016-12-02
K162859	Allura Xper FD series and Allura Xper OR Table series	Philips Medical Systems Nederland B.V.	OWB	Class II	2016-12-02
K162552	Evs 3643, Evs 3643G	DRTECH Corporation	MQB	Class II	2016-12-02
K162418	Pioneer Plus Catheter	Philips Volcano	PDU	Class II	2016-12-02
K162066	Reliance Spinal Screw System	Reliance Medical Systems, LLC	MNH	Class II	2016-12-02
K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	GE Healthcare	KGI	Class II	2016-12-02
K161329	Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel	Chrono-Log Corp.	JOZ	Class II	2016-12-02
K160566	Cerasorb Ortho Foam	Curasan AG	MQV	Class II	2016-12-02
K160377	V-varnish Premium	Vericom Co., Ltd.	LBH	Class II	2016-12-02
K152813	FS-500DDR Medical Radiographic X-Ray System	Orich Medical Equipment (Tianjin) Co., Ltd.	KPR	Class II	2016-12-02
K152664	TAV System	New Aera, Inc.	ONZ	Class II	2016-12-02
K152266	Altrix Precision Temperature Management System	Stryker Medical	DWJ	Class II	2016-12-02
K163106	CODMAN Integrated Bipolar Cord and Tubing Set	Medos International SARL	GEI	Class II	2016-12-01
K163067	CyMedica e-vive™ System; CY-1000	Cymedica Orthopedics, Inc.	IPF	Class II	2016-12-01
K163053	Lumipulse G E2-III Calibrators	Fujirebio Diagnostics, Inc.	JIT	Class II	2016-12-01
K163019	CareView 750Cw/750C X-ray Flat Panel Detectors	Careray Digital Medical System Co., Ltd.	MQB	Class II	2016-12-01
K163009	Litho	Quanta System Inc.	GEX	Class II	2016-12-01
K162676	Voyant Open Fusion Device	Applied Medical Resources Corp	GEI	Class II	2016-12-01
K162468	ClearCheck	Radformation, Inc.	IYE	Class II	2016-12-01