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 2972 of 3529

510(k) clearances, page 2972 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851160	Van-Tec Guide Wire W/hydromer Coating	Van-Tec, Inc.	KOD	Class II	1985-07-29
K851003	Arterial Filter Afs-Xx /Filter Holder Afs-Hxx	Gish Biomedical, Inc.	DTM	Class II	1985-07-29
K850979	Hemoconcentrator Kit	Omnis Surgical, Inc.	KDI	Class II	1985-07-29
K850799	Rinse Machine Kr-4 Kidney Rinse-4	Medical Technologies International, Inc.	LIF	Class II	1985-07-29
K850740	Sechrist Volume Ventilator Modification	Sechrist Industries Inc			1985-07-29
K852989	Winged Infusion Sets	An-Med Intl.	FPA	Class II	1985-07-26
K852937	The Ivy Pole-Intravenous Bot Trees #1121K & 1221K	Northern Customfab, Inc.	FOX	Class I	1985-07-26
K852904	Esteripapel Bags	Sophlaril Hispania, S. A.			1985-07-26
K852891	Spinal Fixation Instrumentation System	Buckman Co., Inc.			1985-07-26
K852884	Medilog M1	Oxford Medilog, Inc.	DSI	Class II	1985-07-26
K852883	Medilog M3	Oxford Medilog, Inc.	DSI	Class II	1985-07-26
K852858	Stretch Bandage	Cornelia Damsky, Inc.			1985-07-26
K852857	4 X 4' Gauze Pad	Cornelia Damsky, Inc.	EFQ	Unclassified	1985-07-26
K852817	Sterile, Disposable Needle	Fabersanitas, S.A.	GAA	Class I	1985-07-26
K852716	Taylor Percussion Hammer Ss 410 or 420	The Huxley Instrument Corp.	GWZ	Class I	1985-07-26
K852462	Tricot Adhesive Bandage	American White Cross, Inc.	KGX	Class I	1985-07-26
K852310	Naturalyte Bicarbonate Concentrate-Dry Pack	Erika, Inc.	FKQ	Class II	1985-07-26
K852309	Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1	Erika, Inc.	FJK	Class II	1985-07-26
K851973	Diasonics, Berger Stereotactic Neorobiopsy	Diasonics, Inc.	HAW	Class II	1985-07-26
K851952	Varices Injector	Wilson-Cook Medical Inc.	FBK	Class II	1985-07-26
K851236	Haemodialysis Sets & Dialiflex Fistula Needles	Infarkem Corp.	FJK	Class II	1985-07-26
K850977	Compute Rx-Plan	Medicalibration	KPQ	Class II	1985-07-26
K850214	Sterile Catheters-Catheter Peritoneal Long-Term in	Accurate Surgical Instruments Co.	FJS	Class II	1985-07-26
K853034	#335-01 Silic Rub Isola Sleeve for Int #281-03 Siz	Intermedics, Inc.	DXY	Class III	1985-07-25
K853017	Ela Medical Cardiac Pacemakers Multil 2 #1251&2251	Ela Medical, Inc.	DXY	Class III	1985-07-25
K852660	Etch and Bond	Dentsply Intl.	KLE	Class II	1985-07-25
K852464	Hcg, Inc. Medical Laser Endocoagulator Model P.c.	Hcg, Inc.	HQF	Class II	1985-07-25
K852289	Model Sa3 Esophageal Ph Electrode	World Precision Instruments, LLC	FFT	Class I	1985-07-25
K852251	Fresenius Hemoflow F60 & Fresenius Hemoflow F40	Seratronics, Inc.	KDI	Class II	1985-07-25
K851958	Rotatable Polypectomy Snare Pos-1	Wilson-Cook Medical Inc.	KNS	Class II	1985-07-25
K851955	Savary-Gilliard Dilator	Wilson-Cook Medical Inc.	KNQ	Class II	1985-07-25
K851053	Tubulitec Liner	Dental Therapeutics AB	EJK	Class II	1985-07-25
K850898	Medi-Trace Disposable Pressure Transducer	Medi-Trace Products Division	DRS	Class II	1985-07-25
K852903	Toshiba Digital Clinical Thermomter	Toshiba Medical Systems	FLL	Class II	1985-07-24
K852890	Am Fab Side Rails Model 5000	Am Fab, Inc.	FNJ	Class I	1985-07-24
K852841	Rapid Direct Strep a Latex Agglutination Test	Smithkline Diagnostics, Inc.	GTZ	Class I	1985-07-24
K852693	Xen-Rex I	Nuclear Pharmacy, Inc.	IYT	Class II	1985-07-24
K852658	Eten-Gel	Dentsply Intl.	EBF	Class II	1985-07-24
K852593	Sunbeam Dental Care Center, Model No. 6273	Northern Electric Co. Div. of Sunbeam Corp.	EFS	Class I	1985-07-24
K852414	Lyphochek Drug Free Serum(human)	Bio-Rad	DIF	Class I	1985-07-24
K852100	The Henley Board S.i.d. Spinal Immobilization Devi	Henley Board, Inc.	FPD	Class II	1985-07-24
K851664	Model Mb-309H, Sharp Digital Blood Pressure Monito	Sharp Electronics Corp.	DXN	Class II	1985-07-24
K851523	Disposable Plastic Syringes	Transcoject GmbH & Co. KG	FMF	Class II	1985-07-24
K851496	ECG Monitor Model Rm102	Honeywell, Inc.	DXJ	Class II	1985-07-24
K851335	Coach Tm- the Aerobic Fitness Monitor	Biotechnology, Inc.	DRT	Class II	1985-07-24
K844810	New Bard Infection Control Urinary Drainage Bag	C.R. Bard Inc	KNX	Class II	1985-07-24
K844484	Hewlett Packardt Hp 85 W/ Vitatron Ph1 Program Hea	Vitatron Medical BV	KRG	Class III	1985-07-24
K841092	High Pressure Flex. Connecting Tubing	Tronomed, Inc.	DXT	Class II	1985-07-24
K852998	Neisseria - Kwik Plus	Micro-Bio-Logics	JSX	Class I	1985-07-23
K852889	General Diagnostics Rapid E. Coli Test	Warner-Lambert Co.	JTO	Class I	1985-07-23