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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2338 of 3531

510(k) clearances, page 2338 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924008	Sterile Film Wound Dressing	Innovative Technology, Ltd.	MGP	Unclassified	1992-11-24
K923471	Planmed Cytoguide	Planmed Oy	IZH	Class II	1992-11-24
K923303	Sapphire Premiere	Medelec, Ltd.	GWF	Class II	1992-11-24
K923056	Neurosign Model 100	Magstim Inc.	ETN	Class II	1992-11-24
K922905	Fep Ringed Gore-Tex Stretch Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1992-11-24
K922900	Infrared Lamp	Harrier, Inc.	ILY	Class II	1992-11-24
K921408	Light Cure Dentin and Liner Base Product Line	Ultradent Products Inc.	EJK	Class II	1992-11-24
K920739	S-Rom Total Hip Replacement System	Joint Medical Products Corp.	JDI	Class II	1992-11-24
K920508	Bio-Oss Blocks	Geistlich Pharma AG	LYC	Class II	1992-11-24
K920361	Bard Biliary Balloon Dilators	C.R. Bard Inc	FGE	Class II	1992-11-24
K915696	Interspec Apogee Endo-V Probe and Needle Guide	Interspec, Inc.	ITX	Class II	1992-11-24
K913425	Dial-a-Rad Porta Rad Table	Dial-A-Rad	IXQ	Class II	1992-11-24
K924749	Trelex Mesh	Meadox Medicals, Div. Boston Scientific Corp.	FTL	Class II	1992-11-23
K924670	Dentin Relief	Professional Technologies Corp.	KLE	Class II	1992-11-23
K924568	Tube, Lead, and Cord Holder No. 102	Ansley Medical Products, Inc.	KMK	Class I	1992-11-23
K924567	Foley Catheter Tube Holder No. 101	Ansley Medical Products, Inc.	KMK	Class I	1992-11-23
K924566	Restraint, Protective N0. 103	Ansley Medical Products, Inc.	KMK	Class I	1992-11-23
K924348	Ad-Tech's Brain Biopsy Needle for Stereotaxic	AD-Tech Medical Instrument Corp.	HAW	Class II	1992-11-23
K924295	Debracketing Instrument	Unitek Corp.	JEX	Class I	1992-11-23
K924271	Chiba/franseen/westcott/spinal Style Needles	Core Medical, Inc.	FCG	Class II	1992-11-23
K924202	Radifocus(r) (Catheter) Guide Wire	Terumo Medical Corp.	DQX	Class II	1992-11-23
K924198	Modified Site Fiber Optic Module	Chiron Vision Corp.	FCT	Class II	1992-11-23
K924164	Digital Disk Recorder W/dualpath Archive/30-60 Opt	Eigen	JAA	Class II	1992-11-23
K924154	Kinematic MRI Moviemaker	Resonex, Inc.	LNH	Class II	1992-11-23
K924004	Seidel Humeral Locking Nail -- Additional Lengths	Howmedica Corp.	JDS	Class II	1992-11-23
K923512	Operating Room Needle Counter	Sharp-Trap, Inc.	MMK	Class II	1992-11-23
K923315	Nicolet Ark System	Nicolet Instrument Corp.	GWF	Class II	1992-11-23
K923115	Clinisorb	Hermitage Hospital Products, Inc.	NAB	Class I	1992-11-23
K923055	Operating Scissors for Laparoscopic Surgeries	Numed Technologies, Inc.	GCJ	Class II	1992-11-23
K923016	Autologous Blood Collection Set	Advanced Haemotechnologies	CAC	Class II	1992-11-23
K922821	Ysi Models 4700 Foley Catheter Temperature Probes	Yellow Springs Instrument Co., Inc.	EZL	Class II	1992-11-23
K922729	Sparta Wet Dressing, Sodium Chloride	Sparta Surgical Corp.	FRO	Unclassified	1992-11-23
K922666	Transorb(tm) Ulcer & Wound Dressing	Brady Medical Products Co.	NAE	Class I	1992-11-23
K922467	Synchron Total Protein Test --Modified	Beckman Instruments, Inc.	CEK	Class II	1992-11-23
K922404	Tube Grip	Georgia Medical Products, Inc.	KRI	Class I	1992-11-23
K922269	Unipolar Temporary Myocardial Pacing Wire, 6493	The Heart Valve Div. Medtronic Cardiovascular Surg	LDF	Class II	1992-11-23
K922268	Unipolar Pediatric Temporary Pacing Lead Mod. 6491	Medtronic, Inc.	LDF	Class II	1992-11-23
K922182	Unipolar Atrial Temporary Pacing Lead, Model 6492	Medtronic, Inc.	LDF	Class II	1992-11-23
K921962	Lorad Digital Spot Mammography	Lorad Medical Systems, Inc.	IZH	Class II	1992-11-23
K921883	Endoscope	Optimed Technologies, Inc.	GCM	Class II	1992-11-23
K921561	Ysi Models 4400 Foley Catheter Temperature Probes	Ysis, Inc.	EZL	Class II	1992-11-23
K921290	Inman Medical Oil Emulsion Dressing	Inman Medical Corp.	FRO	Unclassified	1992-11-23
K920707	Hollow Motor Drive Unit W/ Torque Controller	Devices for Vascular Intervention, Inc.	MCW	Class II	1992-11-23
K920672	Sunglasses, Non Prescription	Daystone Intl. Corp.	HQY	Class I	1992-11-23
K920015	Quicktest System	Q.I. Medical, Inc.	LHI	Class II	1992-11-23
K915717	Cedeta	D-W Intl.	LWM	Unclassified	1992-11-23
K904663	Auto Sash (Tm)	Block Medical, Inc.	FPA	Class II	1992-11-23
K924210	Namtai Electronic Blood Pressure Meter	Nam Tai Electronics (Canada), Ltd.	DXN	Class II	1992-11-20
K924077	Handisol	National Biological Corp.	FTC	Class II	1992-11-20
K923654	Poly Diagnost Cdx	Xre Corp.	IZI	Class II	1992-11-20