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 2257 of 3531

510(k) clearances, page 2257 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932363	Uropaper Eiken Gk	Tanabe U.S.A., Inc.	JIL	Class II	1993-11-16
K932061	Miracle Glove Under the Glove Gloving Cream	Advanced Chemical Technology, Inc.	KGO	Class I	1993-11-16
K932049	Stanbio Ast/got (Liqui-UV) Test Set, Cat No. 9020	Stanbio Laboratory	CIT	Class II	1993-11-16
K931897	Uropaper	Tanabe U.S.A., Inc.	JIL	Class II	1993-11-16
K930831	Mg II Porous Knee System Femoral Components	Zimmer GmbH	JWH	Class II	1993-11-16
K930434	Plumemaster Smoke Evacuation System	Sorenson Laboratories, Inc.	FYD	Class II	1993-11-16
K926384	Statak & Mini-Statak Soft Tissue Attachment Device	Zimmer GmbH	JDR	Class II	1993-11-16
K925093	System 6300 Series High Performance Amino Acid Ana	Beckman Instruments, Inc.	JJF	Class I	1993-11-16
K923394	Menlo Care Aquastent Set	Menlo Care, Inc.	FAD	Class II	1993-11-16
K911288	Orion	Pfizer Laser Systems	GEX	Class II	1993-11-16
K910826	Orion Yag Laser System Ophthalmology	Pfizer Laser Systems	GEX	Class II	1993-11-16
K933432	Stago Factor IX-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1993-11-15
K933400	Kendall Curity 100% Silicone Foley Catheter W/temperature Sensor	Kendall Healthcare Products Co. Div.Of Tyco Health	KOD	Class II	1993-11-15
K933092	Tas Analyzer	Cardiovascular Diagnostic Services	GKP	Class II	1993-11-15
K932876	Diastat Anti-Nuclear Antibody (Ana) Kit	Shield Diagnostics, Ltd.	LKJ	Class II	1993-11-15
K932851	Disposable Penile Blood Pressure Cuffs	D. E. Hokanson, Inc.	DXQ	Class II	1993-11-15
K932732	Aca(r) Digoxin Analytical Test Pack (Dgn)	Dupont Medical Products	KXT	Class II	1993-11-15
K932217	Major, Minor, Basin Trays (Packs)	Associated Medical Products Co.	LRO	Class II	1993-11-15
K931927	Victoreen Model 530	Victoreen, Inc.	IYE	Class II	1993-11-15
K926399	Cutifilm(r) Film	Beiersdorf, Inc.	MGP	Unclassified	1993-11-15
K914714	Bone Drills or Taps	Implant Corp. of America	DZE	Class II	1993-11-15
K934548	All-Vue & Gamma-Vue Vial Shields	Victoreen, Inc.	IWW	Class I	1993-11-12
K934400	Revo Classic/shapes Sunglasses	Revo, Inc.	HQY	Class I	1993-11-12
K934362	Nuclear Associates Glassers	Victoreen, Inc.	IWS	Class I	1993-11-12
K934085	Modification of Surgical Eyeshield Mask	American Threshold Industries, Inc.	HOY	Class I	1993-11-12
K933985	Microwave Insurg Introducer	Boston Scientific Corporation	GCJ	Class II	1993-11-12
K933720	Instrument Actuating Device (Iad)	Unisurge, Inc.	GCJ	Class II	1993-11-12
K933645	ECG Gating Hardware for Mrp-5000 and Mrp-7000	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1993-11-12
K933448	Manan Adapter for Bip Biopsy Device	Argon Medical Devices, Inc	KNW	Class II	1993-11-12
K933380	Reverse Surve Niti Arch Wire	G & H Wire Company	DZC	Class I	1993-11-12
K933379	Stainless Steel Arches	G & H Wire Company	DZC	Class I	1993-11-12
K933378	Reverse Curve Niti Arch Wire Repacker Relabeter	G & H Wire Company	DZC	Class I	1993-11-12
K933376	Niti Arch Wire on a Spool	G & H Wire Company	DZC	Class I	1993-11-12
K932681	Pressureguard IV	Span-America Medical Systems, Inc.	FNM	Class II	1993-11-12
K932451	Hanaulux 2005 Surgical Light	Heraeus Instruments GmbH	FTD	Class II	1993-11-12
K932296	Jr -- Ophthalmic Argon Laser	Carson Laserworks	HQF	Class II	1993-11-12
K932051	Tote-L-Vac	Aeros Instruments, Inc.	BTA	Class II	1993-11-12
K931866	Site's Cd II Phacoemulsification Handpiece	Site Microsurgical Systems, Inc.	HQC	Class II	1993-11-12
K931254	Goggle Safeguard	Sellstrom Mfg. Co.	HOY	Class I	1993-11-12
K930585	Sunglasses	Daiko S.r.l.	HQY	Class I	1993-11-12
K930066	Buffalo Filter Replacement Filter #Bcchar	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-12
K930065	Buffalo Filter Replacement Filter #Bcr0043	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-12
K930064	Buffalo Filter Replacement Filter #Bcr0030	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-12
K930063	Buffalo Filter Replacement Filter #Bculpa	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-12
K930060	Buff. Filter Replacement Filter #Bst312co,bst306co	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-12
K926477	Bifurcated Suction/irrigat Tubing Set W/push Butto	Core Dynamics, Inc.	GBW	Class I	1993-11-12
K926016	Needle Holders & Access for Lapar Surg-Gu Use	Zinnanti Surgical Instruments, Inc.	GCJ	Class II	1993-11-12
K925959	Forceps for Laparoscopic Surgery Gu Use	Zinnanti Surgical Instruments, Inc.	GCJ	Class II	1993-11-12
K925636	Ahmed Glaucoma Valve Implant	New World Medical, Inc.	KYF	Class II	1993-11-12
K924324	K-1 Infant Transport System W/ Integral Air Compre	K-1 Medical Products, Inc.	FMZ	Class II	1993-11-12