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 2246 of 3531

510(k) clearances, page 2246 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925797	A-Dec 2544 Doctors Ic Micro-Cart	A-dec, Inc.	EIA	Class I	1994-01-06
K924351	Glenroe Elastibite Stimulator	Glenroe Technologies	KMY	Class I	1994-01-06
K935713	Wiley/esposito Dental Guard	Fvtnks	BRW	Class I	1994-01-05
K935458	Audiphon, Model H-11	National Hearing Aid Dist., Inc.	ESD	Class I	1994-01-05
K935217	Lc Dental Hand Instrument	L.C. Dental	EKJ	Class I	1994-01-05
K934793	Scimed Maverick	Scimed Peripheral Interventions	LIT	Class II	1994-01-05
K934719	Extra Large Quad Flex Spine Coil	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-01-05
K934386	Impax 5000	Kulzer GmbH	LMD	Class I	1994-01-05
K933999	Steribase (Accubase)	Centrix, Inc.	EJK	Class II	1994-01-05
K933756	Magnashield CPR Mouth Barrier	Cal West Trading Co.	CBP	Class II	1994-01-05
K933468	Myerson's Permasoft Soft Reline Material	Austenal, Inc.	EBI	Class II	1994-01-05
K933139	3M Vitremer Luting Cement	3M Company	EMA	Class II	1994-01-05
K933105	Xomed-Treace Rigid Rod Lens Endoscope	Xomed-Treace, Inc.	EOB	Class II	1994-01-05
K932890	Cell Saver 5 System	Haemonetics Corporation	CAC	Class II	1994-01-05
K932841	Port-a-Cath Dual Lumen Implantable Venous Access	Pharmacia Deltec, Inc.	LJT	Class II	1994-01-05
K932840	Port-a-Cath Implantable Vascular Access System	Pharmacia Deltec, Inc.	LJT	Class II	1994-01-05
K932095	Port-a-Cath Dual Lumen Implantable Venous Access S	Pharmacia Deltec, Inc.	LJT	Class II	1994-01-05
K930182	Radiation Treatment for Cancer Patients	Northwest Medical Physics Center	IYE	Class II	1994-01-05
K925025	Prism Bone Cement Mixing System	Depuy, Inc.	JDZ	Class I	1994-01-05
K924724	Kinetik Great Toe System	Kinetikos Medical, Inc.	LZJ	Unclassified	1994-01-05
K923737	Model Medilog Rapide	Oxford Medilog, Inc.	BZQ	Class II	1994-01-05
K921993	Els Automatic Tubing Clamp System	Rocky Mountain Research, Inc.	FIG	Class II	1994-01-05
K935550	Abuscreen Online Negative Cal/control Cal Pack and Mil Calibration Pack	Roche Diagnostic Systems, Inc.	DKB	Class II	1994-01-03
K935542	Nickel-Titanium K-Type File	Union Broach, Div. Moyco Industries, Inc.	EKS	Class I	1994-01-03
K935339	Hela Hela Epitheloid Carcinoma	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K935338	Lung Cacinoma, Human Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K935337	Rhabdomyosarcoma Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K935336	Cynomologus Monkey Kidney Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K935287	Iron -II (Fe-II) Method/tech Chem 1(R) 1+Tm System	Miles, Inc.	JIY	Class I	1994-01-03
K935230	Emit Iic Negative Control, Control I and II	Syva Co.	DIF	Class I	1994-01-03
K935064	Endopath Endoscopic Linear Cutter Modification	Ethicon, Inc	OCW	Class II	1994-01-03
K934907	860 Measurment System	Ciba Corning Diagnostics Corp.	CHL	Class II	1994-01-03
K934246	Lung Diploid Human Cells-Wi-38	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934245	Human Foreskin Fibroblast Cells-H.f.f.	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934244	Human Lung Diploid Cells-Mrc-5	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934243	Human Epidermal Carcinoma Larynx Cells-Hep-2	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934242	Buffalo Green Monkey Kidney Cells-B.g.m.k.	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934241	Mccoy Culture Cells-Mccoy	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934240	Kidney Africian Green Monkey Cells-Vero	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934239	Kidney African Green Monkey Cells-Cv-1	Advanced Clinical Diagnostics	KIR	Class I	1994-01-03
K934008	Megabeam Lateral Fire Fiber Optic Delivery Syst	Ceram Optec, Inc.	GEX	Class II	1994-01-03
K933696	Sigma Electrolyte Reference Reagent	Sigma Chemical Co.	JFL	Class II	1994-01-03
K933583	Nonrebreathing Valve	Hans Rudolph, Inc.	KGB	Class I	1994-01-03
K933369	Cuda Products Corp. Lightsources	Cuda Products Co.	FCW	Class II	1994-01-03
K933020	Mod. Phantom 5 Plus Urol. Balloon Dilation Catheter	Boston Scientific Corporation	EYB	Class II	1994-01-03
K932439	Spectacle Frames	Styl-Rite Optics, Inc.	HQZ	Class I	1994-01-03
K932205	Ercp Catheter, Hydrophilic Coated	Wilson-Cook Medical Inc.	GBX	Class I	1994-01-03
K932151	Floats Sunglasses	Floats, Inc.	HQY	Class I	1994-01-03
K921868	Endocrine Sciences Products Igfbp3 Radioimmuno Kit	Endocrine Sciences Products	CFL	Class I	1994-01-03
K934690	Kerr Optibond, Modification	Kerr Corporation (Danbury)	KLE	Class II	1993-12-30