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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2916 of 3529

510(k) clearances, page 2916 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854124	Craigwell Aid Ha300	Craigwell Electronics, Ltd.	ESD	Class I	1986-03-26
K854023	Norelco Electronic Digital Bp Meter Hc3501	Philips Park	DXQ	Class II	1986-03-26
K860971	Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)	Den-Mat Corp.	KLE	Class II	1986-03-25
K860959	Dependabond	Ortho Source	DYH	Class II	1986-03-25
K860648	Barron Twin Blade Trephine for Eppikaratophakia	Precision Instruments, Inc.	HRH	Class I	1986-03-25
K860541	Solution Administration Set	Travenol Laboratories, S.A.	FPA	Class II	1986-03-25
K860346	Kerr Porcelite	Kerr Corporation (Danbury)	KLE	Class II	1986-03-25
K860337	Van-Tec Ureteral Anesthe. Stone Displacement Cath.	Van-Tec, Inc.	KOD	Class II	1986-03-25
K860270	Van-Tec Deflecting Rotating Segura Basket	Van-Tec, Inc.	FFL	Class II	1986-03-25
K860269	Van-Tec Deflecting Loop Retriever	Van-Tec, Inc.	FFL	Class II	1986-03-25
K855229	Cfm-10 Vingmed Color Flow Mapping System	Vingmed, Inc.	DXK	Class II	1986-03-25
K855182	Alloy for Metal Crown & Bridge Yellow Pd #46 & #65	Williams Gold Refining Co., Inc.	EJS	Class II	1986-03-25
K854950	Bed Patient Monitor	Clearview Electronics Corp.	KMI	Class I	1986-03-25
K854829	Densco Prophy Paste	Scientific Pharmaceuticals, Inc.	EJR	Class I	1986-03-25
K854691	Diamond Burs-Handpiece	Almore Intl., Inc.	EJL	Class I	1986-03-25
K854690	Diamonds Burs-Composit Finishing	Almore Intl., Inc.	EJL	Class I	1986-03-25
K854638	Cedia Digoxin Assay	Microgenics Corporation	KXT	Class II	1986-03-25
K860912	Ps2 Brand Mammaplasty	Professional Services for Surgeons, Ltd.	FTY	Class I	1986-03-24
K860804	Medical Adhesive Tape	W.R. Grace & Co.-Conn.	KGX	Class I	1986-03-24
K860718	Electrosurgery Pencil, Model 767	Birtcher Corp.	GEI	Class II	1986-03-24
K860687	Birt-a-Switch, Dsp Push Button, Model No. 768	Birtcher Corp.	GEI	Class II	1986-03-24
K860605	Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic Filter	Simplivia Healthcare Ltd.	FPA	Class II	1986-03-24
K860086	Enteral Nutrition Pumps Pn 1000 and Vm 05	Vial Medical, Ltd.	FRN	Class II	1986-03-24
K860022	Paragon Micro-Loops	Paragon Medical and Scientific, Inc.			1986-03-24
K854365	IV Sets with No Phthalate Plasticizer Components	Simplivia Healthcare Ltd.	FPA	Class II	1986-03-24
K860706	IV Band (Intravenous Catheter Assesory)	T. G. & E. Medical	KMK	Class I	1986-03-21
K860358	Fleischman-Swartz Endo-Ocular Probe (Sterile)	Hgm, Inc.	HQF	Class II	1986-03-21
K860148	Mazzocco/frenchik Folder	Staar Surgical AG	KYB	Class I	1986-03-21
K855246	Aurora M Medical Dye Laser	Cooper Lasersonics, Inc.	GEX	Class II	1986-03-21
K853599	Litton Datamedix Blood Pressure Monitor Ni	Litton Datamedix	DXN	Class II	1986-03-21
K852615	R.r. Aghi Hypodermic Single Lumen Needle	Medical Hospital Equipment	FMI	Class II	1986-03-21
K860937	Mark 4 Liquid Oxygen System	Medtronic, Inc.	BYJ	Class II	1986-03-20
K860885	Straight Connectors, 15Mm, 30Mm & 19Mm	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-20
K860882	Disposable Catheter	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-20
K860880	Ventilator Circuits (Various Types)	Dhd Medical Products Div. Diemolding Corp.	BZO	Class I	1986-03-20
K860879	Disposable Ventilator Circuits	Dhd Medical Products Div. Diemolding Corp.	BZO	Class I	1986-03-20
K860878	British Breathing Circuit System	Dhd Medical Products Div. Diemolding Corp.	BZA	Class I	1986-03-20
K860877	Flextube, Connecting Tubing	Dhd Medical Products Div. Diemolding Corp.	BYX	Class I	1986-03-20
K860875	Cirrus Drug Nebulizer Mk III	Dhd Medical Products Div. Diemolding Corp.	CCQ	Class I	1986-03-20
K860873	Venturi Mask/adult & Paediatric	Dhd Medical Products Div. Diemolding Corp.	BYF	Class I	1986-03-20
K860606	Radiacare Intraoperative Radiotherapy System	Bionix, LLC	LHN	Class II	1986-03-20
K860532	Kerr Pol-E-Lastic Dental Impression Material	Kerr Corporation (Danbury)	ELW	Class II	1986-03-20
K860439	Dw217 #18 Crown/bridge & Dw218 #24 Ceramic Alloys	Williams Gold Refining Co., Inc.	EJS	Class II	1986-03-20
K860187	Myograph 2000 - Neuro. Trans. Monitor & Recording	Biometer Intl. A/S	BXN	Class II	1986-03-20
K860186	Myotest - Nerve Stimulator	Biometer Intl. A/S	BXN	Class II	1986-03-20
K855021	Laryngeal Mirror Pre-Warmer	JEDMED Instrument Company	ETF	Class I	1986-03-20
K854956	Respigraph	Respitrace Corp.	BZK	Class II	1986-03-20
K854713	Cotton Neurological Sponge	American Silk Sutures, Inc.	HBA	Class II	1986-03-20
K854668	5.0 Mhz Linear Array Sonoline Probe	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-03-20
K854667	7.5 Mhz Linear Array Sonoline Probe	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-03-20