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 463 of 3528

510(k) clearances, page 463 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191291	Wallace Dual Lumen Oocyte Recovery System	CooperSurgical, Inc.	MQE	Class II	2019-06-12
K191115	RS85 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-06-12
K191064	Argon Handset	New Deantronics Taiwan Ltd.	GEI	Class II	2019-06-12
K191055	HS40 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-06-12
K191038	On Call Express Voice Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2019-06-12
K190521	Aequalis Ascend Flex Shoulder System	Tornier S.A.S.	KWS	Class II	2019-06-12
K190422	Viveve System 2.0	Viveve Medical, Inc.	GEI	Class II	2019-06-12
K190185	Phasix ST Mesh with Open Positioning System	C.R. Bard Inc	OWT	Class II	2019-06-12
K190177	J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,	Ranfac Corp.	KNW	Class II	2019-06-12
K190016	Lateral Plate System	Corelink, LLC	KWQ	Class II	2019-06-12
K183692	Avid IF2	Vision Quest Industries Inc./Dba VQ Orthocare	LIH	Class II	2019-06-12
K183691	PENTAX Medical ENT Video Imaging System	PENTAX of America, Inc.	EOB	Class II	2019-06-12
K183335	Medline Poly-Cath Red Polymer Urethral Catheter	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2019-06-12
K183046	Aquilion ONE (TSX-305A/6) V8.9 with AiCE	Canon Medical Systems Corporation	JAK	Class II	2019-06-12
K182749	Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump	Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.	HGX	Class II	2019-06-12
K180511	Eon FR	Dominion Aesthetic Technologies, Inc.	PKT	Class II	2019-06-12
K172232	LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600	Ams Diagnostics	JGS	Class II	2019-06-12
K191285	Spine & Trauma Navigation	Brainlab, Inc.	OLO	Class II	2019-06-11
K191271	T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System	Stryker Trauma GmbH	HSB	Class II	2019-06-11
K191268	Force Fiber Suture	Teleflex Medical Incorporated	GAT	Class II	2019-06-11
K191226	Arthrex SwiveLock Suture Anchor	Arthrex GmbH	MAI	Class II	2019-06-11
K182713	Scoreflex PTA Scoring Balloon Catheter	Orbusneich Medical Trading, Inc.	PNO	Class II	2019-06-11
K182656	JAMBRO Single Core A Sterilization wrap	Jiangsu Zhande Medical Supplies Co., Ltd.	FRG	Class II	2019-06-11
K182416	NOVA Minimally Invasive System	Baui Biotech Co., Ltd.	NKB	Class II	2019-06-11
K191310	Insight Essentials DRF Digital Imaging System	Imaging Engineering, LLC	JAA	Class II	2019-06-10
K191072	7410 Ultrasound System (MyLabSigma)	Esaote S.p.A.	IYN	Class II	2019-06-10
K190814	AccuFill Bone Substitute Material	Zimmer Knee Creations	MQV	Class II	2019-06-10
K190220	Vista FS, Vista FS Liquid	Inter-Med/Vista Dental Products	MVL	Unclassified	2019-06-10
K183630	SPINEART Navigation Instrument System	Spineart SA	OLO	Class II	2019-06-10
K183104	Mini Cannulated Headed and Headless Screw Set	Stryker Corp.	HWC	Class II	2019-06-10
K182650	Arzzt Distal Radius and Ulna System	Truemed Group, LLC	HRS	Class II	2019-06-10
K190216	SpaceFlex Knee	G21, S.r.l.	MBB	Class II	2019-06-09
K191316	VITROS XT Chemistry Products ALB-TP Slides	Ortho-Clinical Diagnostics, Inc.	CIX	Class II	2019-06-07
K191231	Andorate Auxiliary Water Connector, Andorate Valves Set	Smartdata Suzhou Co., Ltd	ODC	Class II	2019-06-07
K190916	VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20	VitalConnect, Inc.	DRG	Class II	2019-06-07
K190503	CeraSeal	Meta Biomed Co., Ltd.	KIF	Class II	2019-06-07
K190388	RIVAL View Plating Systems and Reduce Fracture Plating Systems	Orthofix SRL	HRS	Class II	2019-06-07
K190057	DJO Acetabular System	Encore Medical, LP	LPH	Class II	2019-06-07
K190051	TD Clip	Zephyr Sleep Technologies	LRK	Class II	2019-06-07
K183649	Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable	Baylis Medical Co., Inc.	DRF	Class II	2019-06-07
K183632	Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable	Baylis Medical Co., Inc.	DRF	Class II	2019-06-07
K183311	Ivenix Infusion System (IIS)	Fresenius Kabi USA, LLC	FRN	Class II	2019-06-07
K183229	Argen Clear Aligner	The Argen Corporation	NXC	Class II	2019-06-07
K182573	Hailie Sensor	Adherium (Nz), Ltd.	CAF	Class II	2019-06-07
K182519	Miha Bodytec II	Miha Bodytec GmbH	NGX	Class II	2019-06-07
K182429	Masimo O3 Regional Oximeter System	Masimo Corporation	MUD	Class II	2019-06-07
K182145	tün® ultrasonic tips product family	Engineered Endodontics	ELC	Class II	2019-06-07
K180952	Ceramic Bracket	Mem Dental Technology Co Ltd	NJM	Class II	2019-06-07
DEN180057	IB-Stim	Innovative Health Solutions (Ihs), Inc.	QHH	Class II	2019-06-07
K191335	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags	Corinth Medtech, Inc.	HIH	Class II	2019-06-06