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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3186 of 3528

510(k) clearances, page 3186 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822818	Holter Recorder & Playback/analysis Sys	Marquette Electronics, Inc.	DSH	Class II	1982-12-30
K822810	Phadebact Csf Test 20	Pharmacia, Inc.	GTJ	Class II	1982-12-30
K822467	Perfilm Membrane Dressing	Chesebrough-Pond'S U.S.A. Co.	FRO	Unclassified	1982-12-30
K822240	Ethylene Oxide Steriliz. Parametric Rel.	American Mcgaw	KFX	Class II	1982-12-30
K821826	Fep-Ringed Gore-Tex@ Vascular Graft	W. L. Gore & Associates, Inc.	DYF	Class II	1982-12-29
K823744	Porcelain Artificial Teeth	Dentsply Intl.	ELL	Class II	1982-12-28
K823732	Cbm, Core Build-Up Material	Scientific Pharmaceuticals, Inc.	EBD	Class II	1982-12-28
K823690	Ivflo-Hp & Ivfil-Hp	Tri-Med, Inc.	FPB	Class II	1982-12-28
K823686	Reamer Type K Endodontic	United Dental Mfg., Inc.	EKP	Class I	1982-12-28
K823685	File Type H (Hedstroem) Endodontic	United Dental Mfg., Inc.	EKS	Class I	1982-12-28
K823684	File Type K Endodontic	United Dental Mfg., Inc.	EKS	Class I	1982-12-28
K823669	Hearing Aid Unitron #Ue4-H	Unitron Industries, Inc.	ESD	Class I	1982-12-28
K823636	Arm Through for Wheelchair Bk-6459-01 &	Fred Sammons, Inc.	KNO	Class I	1982-12-28
K823635	Cushions for Wheelchair Arms	Fred Sammons, Inc.	KNO	Class I	1982-12-28
K823634	Chair or Bed Leg Extenders	Fred Sammons, Inc.	IKX	Class I	1982-12-28
K823633	Turners for Knobs	Fred Sammons, Inc.	IKW	Class I	1982-12-28
K823632	Long Handled Folding Hairbrush	Fred Sammons, Inc.	ILW	Class I	1982-12-28
K823628	Leather & Velcro Shoe Fastener	Fred Sammons, Inc.	ILD	Class I	1982-12-28
K823627	Leather I Velcro Shoe Fastener Repair	Fred Sammons, Inc.	ILD	Class I	1982-12-28
K823623	Inflatable Heavy Plastic Exerciser	Fred Sammons, Inc.	ION	Class I	1982-12-28
K823607	Carpet Sweeper	Fred Sammons, Inc.	IKW	Class I	1982-12-28
K823606	Plastic Break Resistant Mirror	Fred Sammons, Inc.	ILS	Class I	1982-12-28
K823605	Portable Electric Can Opener	Fred Sammons, Inc.	IKW	Class I	1982-12-28
K823604	Rod W/hook to Pull Clothes on	Fred Sammons, Inc.	ILD	Class I	1982-12-28
K823603	Formed Plastic Panty Hose Aid	Fred Sammons, Inc.	ILD	Class I	1982-12-28
K823591	Ameda Hand Breast Pump	Burditt & Calkins-Siemens-Elema	HGY	Class I	1982-12-28
K823570	Corning 170 Ph/blood Gas Analyzer	Corning Medical & Scientific	CHL	Class II	1982-12-28
K823557	Removawell Plate Lid	Dynatech Corp.	LIB	Class I	1982-12-28
K823548	Compression Hip Screw Side-Plate	Howmedica Corp.	KTT	Class II	1982-12-28
K823536	Intralig	Miltex Instrument Co.	EJI	Class II	1982-12-28
K823524	Oxygen Concentrator	C.R. Bard Inc	CAW	Class II	1982-12-28
K823522	Dilulab 230	Innovative Medical Systems, Inc.	GKH	Class I	1982-12-28
K823520	Fibrosystem	BD Becton Dickinson Vacutainer Systems Preanalytic	GKQ	Class I	1982-12-28
K823510	Curay Anterior/posterior Restorative	Scientific Pharmaceuticals, Inc.	EBF	Class II	1982-12-28
K823507	Tandem-E -Ige Immunoezymetric Assay	Hybritech, Inc.	DGC	Class II	1982-12-28
K823498	Para 12	Streck Laboratories, Inc.	GLQ	Class II	1982-12-28
K823496	Arthroscopic Irrigation Sets-2C4030/31	Travenol Laboratories, S.A.	GBX	Class I	1982-12-28
K823476	Gammadab Lh Radio-Kit #Ca-1508	Clinical Assays, Inc.	CEP	Class I	1982-12-28
K823472	Ultra Chem Ban-UV #65080 & 65081	EMD Millipore Corporation	CDQ	Class II	1982-12-28
K823462	Single Vial Amylase Pnp Test	Boehringer Mannheim Corp.	JFJ	Class II	1982-12-28
K823450	Female External Urinary Appliance	Diamed Division Ill. Tool Works, Inc.	KNX	Class II	1982-12-28
K823445	Alkphor System	California Immuno Diagnostic, Inc.	CIN	Class II	1982-12-28
K823411	Pediatric Urine Collector	Sage Products LLC	KNX	Class II	1982-12-28
K823368	Dade Esr Kit	American Dade	JPH	Class I	1982-12-28
K823355	Coulter-Counter #S Plus IV & Lyse S +D	Coulter Electronics, Inc.	GKZ	Class II	1982-12-28
K823348	H. Influenza B Antisera for Cie	Diagnostica, Inc.	GRP	Class II	1982-12-28
K823344	Hematology Analyzer	Abbott Diagnostics	GKL	Class II	1982-12-28
K823329	Papincolabu Stain Ea-36/50/65 & Og-6	Accra Laboratories, Inc.	HZL	Class I	1982-12-28
K823328	Harris Hematoxylin	Accra Laboratories, Inc.	HYK	Class I	1982-12-28
K823292	Immophase Tm Hpl Radioimmunoassay	Corning Medical & Scientific	JMF	Class II	1982-12-28