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 652 of 3529

510(k) clearances, page 652 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160254	GORE DrySeal Flex Introducer Sheath	W. L. Gore & Associates, Inc.	DYB	Class II	2016-05-12
K153703	Guiding Catheter	Texasmedical Technologies, Inc.	DQY	Class II	2016-05-12
K153670	Genteel Lancing Device	Genteel, LLC	FMK	Class II	2016-05-12
K153316	Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)	Medtronic, Inc.	KGO	Class I	2016-05-12
K153239	Lsfg-Navi	Softcare Co., Ltd.	HKI	Class II	2016-05-12
K152749	moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager	Moor Instruments Ltd.	DPT	Class II	2016-05-12
K152745	ReNew Sterilization Trays(Catalog #3708 and #3709)	Microline Surgical, Inc	KCT	Class II	2016-05-12
K152630	VERIFY STEAM Integrating Indicator	STERIS Corporation	JOJ	Class II	2016-05-12
K150980	Venous Assist System	Daesung Maref Co.,Ltd	JOW	Class II	2016-05-12
K161000	Biodesign Otologic Repair Graft	Cook Biotech Incorporated	KHJ	Class II	2016-05-11
K152825	Catalyst CSR Shoulder System	CATALYST ORTHOSCIENCE Inc	KWT	Class II	2016-05-11
K152443	Vericore Gradient Temporary Disc	Whip-Mix Corp.	EBG	Class II	2016-05-11
K152429	Slit Lamp Microscope	Shanghai Mediworks Precision Instruments Co., Ltd.	HJO	Class II	2016-05-11
K160319	FiberTak DR	Arthrex GmbH	MBI	Class II	2016-05-10
K160303	Reprocessed Polaris X Steerable Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2016-05-10
K160242	Reprocessed Livewire Steerable Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2016-05-10
K153657	Vanguard XP Knee System	Zimmer GmbH	MBH	Class II	2016-05-10
K152679	Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak	Bio-Rad Laboratories Inc.	PMN	Class II	2016-05-10
K161017	True HD 3MOS Camera System	ConMed Corporation	GCJ	Class II	2016-05-09
K153350	IBS Implant System	Innobiosurg Co., Ltd.	DZE	Class II	2016-05-09
K152431	LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating	Waldemar Link GmbH & Co. KG	KRO	Class II	2016-05-09
K160740	Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology	Medline ReNewal	NLM	Class II	2016-05-06
K160053	Monopolar single-use HF cable	Olympus Winter & Ibe GmbH	GEI	Class II	2016-05-06
K153615	NeoFuse HA Enhanced PLIF/TLIF	Ht Medical, LLC	MAX	Class II	2016-05-06
K153506	Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit	Consure Medical Pvt, Ltd.	KNT	Class II	2016-05-06
K153139	Achieve ST Mapping Catheter, Catheter Connecting Cable	Medtronic, Inc.	DRF	Class II	2016-05-06
K153111	TOUAREG CloseFit™ UNP 2.75mmD	Adin Dental Implants Systems, Ltd.	DZE	Class II	2016-05-06
K153008	INVISION Total Ankle Revision System	Wrightmedicaltechnologyinc	HSN	Class II	2016-05-06
K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	Sybron Dental Specialties, Inc.	KIF	Class II	2016-05-06
K152911	EarlySense Insight Sytem	Earlysense, Ltd.	BZQ	Class II	2016-05-06
K152769	Fremap Electrode	AD-Tech Medical Instrument Corp.	ETN	Class II	2016-05-06
K152717	Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit	William A. Cook Australia Pty, Ltd.	MQL	Class II	2016-05-06
K152680	TD-1035 Thermometer	Taidoc Technology Corporation	FLL	Class II	2016-05-06
K152415	Digital Blood Pressure Monitor	Suzhou Sunspirit Co., Ltd.	DXN	Class II	2016-05-06
K152205	Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor	Heidelberg Engineering GmbH	OBO	Class II	2016-05-06
K152043	Diagnostic Station DS20	Schiller, AG	DPS	Class II	2016-05-06
K161047	LOGIQ P9 and LOGIQ P7	GE Healthcare	IYN	Class II	2016-05-05
K161021	HydroMARK Breast Biopsy Site Marker	Devicor Medical Products Inc	NEU	Class II	2016-05-05
K160952	Alma Diode Tabletop Laser	Alma, Ltd.	GEX	Class II	2016-05-05
K160951	Philips Efficia CMS200 Central Monitoring System	Philips North America LLC	MHX	Class II	2016-05-05
K160428	Certex Spinal Fixation System	Xtant Medical Holdings, Inc.	NKG	Class II	2016-05-05
K160324	Cervical Interbody Fusion System	Evolution Spine, LLC	ODP	Class II	2016-05-05
K153620	Enovare Ultrasound System	Oreon Technologies, Inc.	IYO	Class II	2016-05-05
K153585	Flip Button Suture Anchor	First Ray, LLC	MBI	Class II	2016-05-05
K153520	Electronic Pulse Stimulator	JKH Health Co., Ltd.	NUH	Class II	2016-05-05
K152930	PeriFlux6000	Perimed AB	DPW	Class II	2016-05-05
K152682	Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit	Willian A. Cook Australia Pty, Ltd.	MQL	Class II	2016-05-05
K152006	Cogent Hemodynamic Monitoring System	Abbott Medical	DXQ	Class II	2016-05-05
K151362	HC Spinal System	Hung Chun Bio-S Co., Ltd.	MNH	Class II	2016-05-05
K150364	ERBE ESU Model VIO dV with Accessories	ERBE Elektromedizin GmbH	GEI	Class II	2016-05-05