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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 329 of 3528

510(k) clearances, page 329 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211158	NTI ClenchGuard	Boyd Research	OBR	Unclassified	2021-09-17
K210441	Incontinence Probe	Shenzhen Med-Link Electronics Tech Co.,Ltd	KPI	Class II	2021-09-17
K210399	Unifine SafeControl	Owen Mumford Limited	FMI	Class II	2021-09-17
K203845	Philips IntelliSite Pathology Solution	Philips Medical Systems Nederland B.V.	PSY	Class II	2021-09-17
K203762	Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector	Medtronic, Inc.	CCK	Class II	2021-09-17
K203418	Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))	Ningbo Ouhan Medical Device Co., Ltd.	FXX	Class II	2021-09-17
K203155	BreatheSuite MDI V1	Breathesuite, Inc.	CAF	Class II	2021-09-17
K203141	Uramix CuraWay Biopsy Needle	Uramix, Inc.	KNW	Class II	2021-09-17
K202790	Syntec Orthodontic Mini Screw Extended System	Syntec Scientific Corp.	OAT	Class II	2021-09-17
K201832	Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5	Olympus Medical Systems Corp.	HET	Class II	2021-09-17
K212742	GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating	Waldemar Link GmbH & Co. KG	JWH	Class II	2021-09-16
K212641	StrataMR II Valves and Shunts	Medtronic Neurosurgery	JXG	Class II	2021-09-16
K212604	Symbia VA10A Family	Siemens Medical Solutions USA, Inc.	KPS	Class II	2021-09-16
K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	Septodont	KIF	Class II	2021-09-16
K212021	6430 MyLabX75, 6430 MyLab XPro75	Esaote S.p.A.	IYN	Class II	2021-09-16
K211512	VISIONAIRE UK Patient Matched Cutting Guides	Smith & Nephew, Inc.	HSX	Class II	2021-09-16
K211479	Blue Nitrile Examination Glove Powder Free	Aspen Glove Sdn. Bhd.	LZA	Class I	2021-09-16
K211478	Sterile Latex Surgical Gloves Powder Free	Aspen Glove Sdn. Bhd.	KGO	Class I	2021-09-16
K203112	Disposable Medical Mask	Yangzhou Runyi Arts & Crafts Co., Ltd.	FXX	Class II	2021-09-16
K203111	Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System	Medtronic, Inc.	DTZ	Class II	2021-09-16
K212710	GLOBAL UNITE™ Platform Shoulder System	Depuy Ireland UC	PHX	Class II	2021-09-15
K212606	BeamSite	Doseoptics LLC	IYE	Class II	2021-09-15
K212556	mi-eye 3 needlescope with cannula, mi-tablet 3	Trice Medical	HRX	Class II	2021-09-15
K212009	Disposable Nitrile Gloves	Jiangsu Shenglijie Safety Products Co., Ltd.	LZA	Class I	2021-09-15
K211276	Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters	Innovative Health, LLC.	NLH	Class II	2021-09-15
K211227	HTx Disposable Hysteroscope System	Acuvu, Inc.	HIH	Class II	2021-09-15
K210818	TrueCare Biomedix Tamper Evident Cap	Us Infusion Inc. D/B/A Truecare Biomedix-USA	FMF	Class II	2021-09-15
K210118	INFRARED BODY THERMOMETER (Model: YK-001)	Longnan Renzhong Medical Equipment Co., Ltd.	FLL	Class II	2021-09-15
K210085	HealthCCSng	Zebra Medical Vision, Ltd.	JAK	Class II	2021-09-15
K203649	TruAbutment DS, TruBase	TruAbutment Inc.	NHA	Class II	2021-09-15
K203492	Instrument tray, for semi-rigid ureteroscope	Olympus Winter & Ibe GmbH	KCT	Class II	2021-09-15
K202885	GlucoSure HT Plus Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2021-09-15
K202369	Rxs 1000	Rolence Enterprise Co., Ltd.	MUH	Class II	2021-09-15
K212678	Viveve System, Viveve 2.0 System	Viveve Medical, Inc.	GEI	Class II	2021-09-14
K212291	Phoenix	Sedecal S.A.	IZL	Class II	2021-09-14
K211738	Rotarex Atherectomy System	C.R. Bard Inc	MCW	Class II	2021-09-14
K211494	Polaris X Unidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	DRF	Class II	2021-09-14
K211474	Kleiner KG2 System	Baat Medical Products B.V.	MAX	Class II	2021-09-14
K211464	Nitta M&T Safety Box	Nitta M&T (Thailand) Co Ltd	MMK	Class II	2021-09-14
K211389	Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation	Magstim Inc.	OBP	Class II	2021-09-14
K211305	ANNE One	Sibel, Inc.	DRG	Class II	2021-09-14
K211283	Compressible Limb and Circulation Therapy System, Model POWER-Q2300	Wonjin Mulsan Co., Ltd.	IRP	Class II	2021-09-14
K210586	Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system	Cardiovascular Systems Incorporated	MCW	Class II	2021-09-14
K210461	End Cap	Medical Components Inc (Medcomp)	MSD	Class II	2021-09-14
K210184	Wilson Tech Disposable Medical Face Mask	Wilson Tech (International) Limited	FXX	Class II	2021-09-14
K202396	VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)	bioMerieux, Inc.	LON	Class II	2021-09-14
K193650	LIAISON Ferritin	Diasorin Inc.	DBF	Class II	2021-09-14
K212685	Konicaminolta Di-X1	Konica Minolta, Inc.	LLZ	Class II	2021-09-13
K212412	Iris-Xp	Medicore Co. Ltd.	LHQ	Class I	2021-09-13
K212214	HandX	Human Xtensions, Ltd.	GCJ	Class II	2021-09-13