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 2345 of 3531

510(k) clearances, page 2345 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923349	Fungi Fluor Kit	Polysciences, Inc.	LYF	Class II	1992-10-20
K922630	Mopylen	S. Jackson, Inc.	GAW	Class II	1992-10-20
K922605	Trendelenburg Ultrasound Table, Model # 056-603	Biodan Medical Systems, Ltd.	IYO	Class II	1992-10-20
K922604	Deluxe Adjustable Height Ultrasound Table	Biodan Medical Systems, Ltd.	IYO	Class II	1992-10-20
K922530	Visitec Microsurgical Suture	Visitec Co.	GAR	Class II	1992-10-20
K921888	Sharpe Endodissector	Paladin Medical, Inc.	HET	Class II	1992-10-20
K921192	CT Sytec 6000 Computed Tomography System	GE Healthcare	JAK	Class II	1992-10-20
K920319	Sienet Image Display Workstations, Image Acquisiti	Siemens Gammasonics, Inc.	LLZ	Class II	1992-10-20
K915749	Sharpe Endoligature Carrier	Paladin Medical, Inc.	HET	Class II	1992-10-20
K915747	Sharpe Endoforceps	Paladin Medical, Inc.	HET	Class II	1992-10-20
K915744	Sharpe Endohemostat	Paladin Medical, Inc.	HET	Class II	1992-10-20
K915500	Lester Press Fit Hip Prosthesis	Kirschner Medical Corp.	JDI	Class II	1992-10-20
K915396	Osteonics Zirconia C-Taper Femoral Bearing Head	Osteonics Corp.	LZO	Class II	1992-10-20
K915326	Portable Limb Load Monitor (Bmllm-100)	Bar Med Pty, Ltd.	IKE	Class I	1992-10-20
K915138	Ge Sonochrome	GE Healthcare	MAA	Class II	1992-10-20
K924692	Olympus Creatinine Reagent	Olympus Corp.	CGX	Class II	1992-10-19
K924658	Olympus Magnesium Reagent	Olympus Corp.	JGJ	Class I	1992-10-19
K924435	Olympus Calcium Reagent	Olympus Corp.	CIC	Class II	1992-10-19
K924339	Olympus Amylase Reagent	Olympus Corp.	CIW	Class II	1992-10-19
K924136	Premier C. Difficile Toxin a Controls	Meridian Diagnostics, Inc.	LLH	Class I	1992-10-19
K924062	Meritec C. Difficile Controls	Meridian Diagnostics, Inc.	MCB	Class I	1992-10-19
K923774	Disposable Endoilluminator	O.R. Specialties, Inc.	EQH	Class I	1992-10-19
K923629	Ophthalmic Trichiasis Probe	Mira, Inc.	HPS	Class II	1992-10-19
K923407	Medtronic Models 5455L and 5455Sl Surgical Cables	Medtronic, Inc.	LDF	Class II	1992-10-19
K922626	Adept Instrument Positioning Accessory	Andronic Devices, Ltd.	GAD	Class I	1992-10-19
K922625	Adept Endoscopic Positioner	Andronic Devices, Ltd.	GAD	Class I	1992-10-19
K922558	Interlink(tm) Injection Site	Baxter Healthcare Corporation	FPA	Class II	1992-10-19
K922073	Stratus Bhcg Fluorometric Enzyme Immunoassay	Baxter Diagnostics, Inc.	DHA	Class II	1992-10-19
K921553	Lspi Infant Bag Mask	Life Support Products, Inc.	BTM	Class II	1992-10-19
K921396	Platelin L	bioMerieux, Inc.	GFO	Class II	1992-10-19
K921031	Edge Medical Dispensing Pin	Edgewater Medical Center	LHI	Class II	1992-10-19
K920989	Surgical Instrument Kit, Disposable	Ulti-Med Intl., Inc.	KDD	Class I	1992-10-19
K920803	Hsg Tray	Unimar, Inc.	HIB	Class II	1992-10-19
K920774	Mvr Collapsible Venous Reservoir Bag	Medtronic, Inc.	DTN	Class II	1992-10-19
K920480	Dressing Chang & Wound Management	Cypress Medical Products LLC	FRG	Class II	1992-10-19
K920284	Drape Utility/surgical Sterile Disposable	Trinity Laboratories, Inc.	KKX	Class II	1992-10-19
K924798	Battery Pack	Portable Power Systems, Inc.	IZL	Class II	1992-10-16
K924635	Alpha-Dent Pit and Fissure Sealant	Wallace A. Erickson & Co.	EBC	Class II	1992-10-16
K924182	Calcimol Lc	Voco GmbH	EJK	Class II	1992-10-16
K924181	Polibond	Voco GmbH	KLE	Class II	1992-10-16
K924012	Fuji Computed Radiography Hi-C653 Dms Crt Image	FUJIFILM Healthcare Americas Corporation	IXK	Class II	1992-10-16
K923949	Sylvan Dental Headlight System	Sylvan Medical Fiberoptics	EBA	Class I	1992-10-16
K923813	Philips Integris V3000 Rotational Angio Function	Philips North America LLC	IZI	Class II	1992-10-16
K923767	Pulse Im Red Cell Test	Pulse Scientific, Inc.	KTN	Class II	1992-10-16
K923736	Gamma 600T	Strichman Medical Equipment, Inc.	KPS	Class II	1992-10-16
K922785	Irrivage	Autovage	EYF	Class I	1992-10-16
K922340	Encore Ss-B	Trinity Biotech USA	LLL	Class II	1992-10-16
K922287	E.z. Port(tm) Radiation Therapy Skin Markers	I.Z.I. Corp.	KPQ	Class II	1992-10-16
K921986	Patient Information Manager (Pim)	Continental X-Ray Corp.	IZH	Class II	1992-10-16
K921577	Scimed Sidewinder Tuohy-Borst Y-Adapter	Scimed Life Systems, Inc.	LIT	Class II	1992-10-16