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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 729 of 3530

510(k) clearances, page 729 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142767	ThinkMed Intermittent Catheter with/without Hydrophilic Coating	Thinkmed Medical Technology Co., Ltd.	GBM	Class II	2015-02-03
K142459	Ebony PTA 0.014 RX Peripheral Dilatation Catheter	Natec Medical Ltd	LIT	Class II	2015-02-03
K141945	Echostar Comfort 1.5T MRI	Alltech Medical Systems America, Inc.	LNH	Class II	2015-02-03
K141666	Fertiligent Slow Release Iui Catheter Kit	Fertiligent, Ltd.	MQF	Class II	2015-02-03
K140575	Engstrom Carestation, Engstrom Pro	GE Healthcare	CBK	Class II	2015-02-03
K131335	Bwmini EEG, Bwminihst, Bwmini Psg	Neurovirtual USA, Inc.	GWQ	Class II	2015-02-03
K142242	PREMIUM, SHELTA Implant Systems	Sweden & Martina Inc	DZE	Class II	2015-02-02
K143633	CREO Stabilization System	Globus Medical, Inc.	NKB	Class II	2015-01-30
K143543	Prelude PF Patellae	Zimmer GmbH	KRR	Class II	2015-01-30
K143232	Universal Digital Interface 2W, UDI 2W	Meridian Medical Systems, LLC	MQB	Class II	2015-01-30
K143179	The LINK® Endo-Model® Knee System	Waldemar Link GmbH & Co. KG	KRO	Class II	2015-01-30
K143178	FilmArray 2.0 System	BioFire Diagnostics, LLC	NSU	Class II	2015-01-30
K143171	FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0	BioFire Diagnostics, LLC	PEN	Class II	2015-01-30
K142957	Ideal pedicle screw spinal system	Jiangsu Ideal Medical Science & Technology Co., Ltd.	MNH	Class II	2015-01-30
K142273	EmboGuide	Philips Medical Systems Nederland B.V.	OWB	Class II	2015-01-30
K141986	Elux 810 Laser	Equipmed North America, Inc.	GEX	Class II	2015-01-30
K141751	Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi Chikai Black, Asahi Neurovascular	Asahi Intecc Co., Ltd.	MOF	Class II	2015-01-30
K141548	High Tibial Osteotomy System	Newclip Technics	HRS	Class II	2015-01-30
K141354	Navajo Pta Balloon Dilatation Catheter	Curative Medical, Inc.	DQY	Class II	2015-01-30
K141189	Nanobone / Granulate	Artoss, Inc.	MQV	Class II	2015-01-30
K140861	Somnotouch Resp	Somnomedics AG	MNR	Class II	2015-01-30
K140852	Vectraplex Cms	VectraCor, Inc.	MSX	Class II	2015-01-30
K133891	Multipulse Tm+1470	Asclepion Laser Technologies GmbH	GEX	Class II	2015-01-30
K143452	Logiq P9, Logiq P7	GE Healthcare	IYN	Class II	2015-01-29
K143281	Ultimax-i	Toshibamedical Systems Corporation	OWB	Class II	2015-01-29
K143199	Capillus 272 Pro	Capillus, LLC	OAP	Class II	2015-01-29
K143155	LISTERINE Sensitivity Defense Mouthrinse	Johnson & Johnson Healthcare Products, Division of Mcneil-Pp	LBH	Class II	2015-01-29
K143129	easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)	Ezisurg Medical Co., Ltd.	GDW	Class II	2015-01-29
K142989	Mini ONE Enteral Extension Set	Applied Medical Technology Inc	PIF	Class II	2015-01-29
K142837	Heine Sigma 250 & Heine Sigma 250 M2	Heine Optotechnik GmbH & Co. KG.	HLJ	Class II	2015-01-29
K142714	S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2015-01-29
K142656	Surgical Gut Suture	Medtronic, Inc.	GAL	Class II	2015-01-29
K142500	One Way Soft Valve	Terumo Cardiovascular Systems Corporation	MJJ	Class II	2015-01-29
K142246	LightStim for Acne/ LightStim for Acne Mini	LED Intellectual Properties LLC	OLP	Class II	2015-01-29
K141210	Quanta Flash Ss-B, Quanta Flash Ss-B Calibrators, and Quanta Flash Ss-B Controls	Inova Diagnostics, Inc.	LLL	Class II	2015-01-29
K134051	Transonic Elsa System	Transonic Systems Inc	DXG	Class II	2015-01-29
K143691	LDLC3 LDL-Cholesterol Gen.3	Roche Diagnostics Operations (Rdo)	LBR	Class I	2015-01-28
K143113	Klassic BiPolar System	Total Joint Orthopedics, Inc.	KWY	Class II	2015-01-28
K142940	Endoskeleton TCS System	Titan Spine, LLC	OVE	Class II	2015-01-28
K142815	S22 Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2015-01-28
K141892	Qk-Systemic Therapeutic Apparatus	Harbin Quanke Medi-Technical Development Co., Ltd.	ILY	Class II	2015-01-28
K141400	Dcceram System	Ceramay GmbH & Co.Kg	EIH	Class II	2015-01-28
K133733	WINSIX Implant System	Biosaf in S.r.l.	DZE	Class II	2015-01-28
K143680	ADVIA Centaur IgE Master Curve Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2015-01-27
K143509	MasterSL femoral stem	Lima Corporate S.p.A.	LZO	Class II	2015-01-27
K143426	Wound Matrix TF	Miromatrix Medical, Inc.	KGN	Unclassified	2015-01-27
K143187	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)	Healgen Scientific LLC	DJG	Class II	2015-01-27
K143063	Stryker SonicPin System, Stryker SonicAnchor System	Stryker Trauma GmbH	HTY	Class II	2015-01-27
K142929	Ligasure Blunt Tip Sealer/Divider	Medtronic, Inc.	GEI	Class II	2015-01-27
K142889	Celerity PICC Tip Confirmation System	Boston Scientific Corporation	LJS	Class II	2015-01-27