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 647 of 3529

510(k) clearances, page 647 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152688	LightLas Multi-Wavelength Medical Laser System	Lightmed Corp.	HQF	Class II	2016-06-15
K161366	ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)	ConforMIS, Inc.	JWH	Class II	2016-06-14
K161362	ASAHI Corsair Armet	Asahi Intecc Co., Ltd.	DQY	Class II	2016-06-14
K161156	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2016-06-14
K160751	Symphion Endoscope and Symphion Cervical Sheath	Boston Scientific Corporation	HIH	Class II	2016-06-14
K160717	ally Warming Liquid Personal Lubricant	Private Label Production, LLC	NUC	Class II	2016-06-14
K160627	Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution	Qfix	IYE	Class II	2016-06-14
K160625	Disposable Hot Biopsy Forceps	Micro-Tech (Nanjing) Co., Ltd.	KGE	Class II	2016-06-14
K160238	Airborne Phototherapy Light	International Biomedical, Ltd.	LBI	Class II	2016-06-14
K153456	Megapulse III Shortwave Diathermy	Accelerated Care Plus Corp.	IMJ	Class II	2016-06-14
K151985	PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter	C.R. Bard Inc	LJS	Class II	2016-06-14
K161062	NR Recorder	Norav Medical Ltd.	MWJ	Class II	2016-06-13
K161035	Medline Singe Patient Use Blood Pressure Cuff	MEDLINE INDUSTRIES, LP - Northfield	DXQ	Class II	2016-06-13
K160829	illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10	Meridian Bioscience Inc	OZX	Class II	2016-06-13
K160729	Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5	Roche Diagnostics GmbH	PMT	Class II	2016-06-13
K160018	Arrow Quickflash Arterial Catheterization Device	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	DQX	Class II	2016-06-13
K153702	M3290B Philips IntelliVue Information Center iX	Philips North America LLC	MHX	Class II	2016-06-13
DEN150007	Magnetic Surgical System	Levita Magnetics International Corp.	PNL	Class II	2016-06-13
K161064	Penumbra System ACE 68 Reperfusion Catheter	Penumbra Inc.	NRY	Class II	2016-06-12
K160739	Cranial COVER	Neos Surgery S.L.	GXR	Class II	2016-06-12
K161363	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2016-06-10
K160995	NEOVIEW Plating System	In2Bones SAS	HRS	Class II	2016-06-10
K160975	Aequalis PerFORM+ Shoulder System	TORNIER Inc.	KWS	Class II	2016-06-10
K160703	NeuroStar TMS Therapy System	Neuronetics Inc.	OBP	Class II	2016-06-10
K160700	ATTUNE Revision Knee System	Depuy (Ireland)	JWH	Class II	2016-06-10
K160555	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	KWS	Class II	2016-06-10
K160496	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2016-06-10
K160364	VersaWrap Tendon Protector	Alafair Biosciences, Inc.	OWW	Class II	2016-06-10
K160095	Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz	Simple Science, LLC	FRO	Unclassified	2016-06-10
K153659	MaxO2ME	Maxtec, LLC	CCL	Class II	2016-06-10
K153434	Pall-Aquasafe Water Filter	Pall International, SARL	NHV	Class II	2016-06-10
K152747	DSG Threaded Drill System	Spineguard, Inc.	PDQ	Class II	2016-06-10
K152744	Diego Elite Drill	Gyrus ACMI, Inc.	ERL	Class II	2016-06-10
K152251	Endobronchial Tube	Henan Tuoren Medical Device Co., Ltd.	CBI	Class II	2016-06-10
K161188	Hepatiq 1.1	Hepatiq, LLC	LLZ	Class II	2016-06-09
K161180	Oak Ridge Products Sharps Containers	Oak Ridge Products	MMK	Class II	2016-06-09
K161001	MILAGRO ADVANCE PEEK Interference Screw	Medos International SARL	MBI	Class II	2016-06-09
K160989	NuVasive® Reline® System	Nu Vasive, Incorporated	NKB	Class II	2016-06-09
K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T	GE Healthcare	LNH	Class II	2016-06-09
K160587	Aquilion ONE (TSX-305A/3) V7.3	Toshibamedical Systems Corporation	JAK	Class II	2016-06-09
K160546	3M Attest Rapid Readout Biological Indicator	3M Company	FRC	Class II	2016-06-09
K160526	Masimo O3 Regional Oximeter System	Masimo Corporation	MUD	Class II	2016-06-09
K160510	Mako 7	Nvision Medical	HIH	Class II	2016-06-09
K160370	BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	JGS	Class II	2016-06-09
K160204	BSD4343 Digital Flat Panel X-ray Detector	Bontech Co., Ltd	MQB	Class II	2016-06-09
K152667	ATOVEN-Reusable Laser Fiber	Diotech Co	GEX	Class II	2016-06-09
K152342	Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover	Abbott Medical	GXR	Class II	2016-06-09
K152011	Lucent Intervertebral Body Fusion Device	Spinal Elements, Inc	MAX	Class II	2016-06-09
K161122	Sony IP Converter NU-IP40S	Sony Electronics Inc.	GCJ	Class II	2016-06-08
K160400	Miromatrix Biological Mesh	Miromatrix Medical, Inc.	OXH	Class II	2016-06-08