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 2298 of 3531

510(k) clearances, page 2298 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931160	Series Star 66 Bekhind the Ear Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1993-06-01
K931112	Model Pb3300 Intra-Arter Blood Gas Monit Sys, Modi	Medtronic, Inc.	CBZ	Class II	1993-06-01
K931043	Mf Ohmeda Style Medical Gas Wall Outlets	Medical Fittings, Inc.	BYX	Class I	1993-06-01
K931041	Star 42 Pp-Sp, Star 42 Pp-Sl (T100)	Maico Hearing Instruments, Inc.	ESD	Class I	1993-06-01
K931040	Mt 80 Sp	Maico Hearing Instruments, Inc.	ESD	Class I	1993-06-01
K931035	Models 33Pp, 33Pp Anr, & 33Pp Super Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1993-06-01
K931033	Mf Chemetron Style Medical Gas Wall Outlets	Medical Fittings, Inc.	BYX	Class I	1993-06-01
K930949	Voyage	Mada Medical Products, Inc.	CAF	Class II	1993-06-01
K930947	Promenade	Mada Medical Products, Inc.	CAF	Class II	1993-06-01
K930427	Std Irrigation Pump	Std Mfg., Inc.	GCJ	Class II	1993-06-01
K930419	Wiltek Biopsy Forceps	Wiltek Medical, Inc.	BWH	Class II	1993-06-01
K926326	Microcare(tm)	American Imex	GZJ	Class II	1993-06-01
K926166	Coast Video Endoscopic Imaging System	Optik	FWF	Class I	1993-06-01
K925856	Safehealth Brand Latex Hypoallergenic Exam Gloves	Motrend International Corp.	LYY	Class I	1993-06-01
K925742	Clarus Cholangiogram Catheter Kit	Clarus Medical Systems, Inc.	GBZ	Class I	1993-06-01
K925635	Torus External Fixation System	Zimmer GmbH	KTW	Class II	1993-06-01
K925215	Sterile Surgical Instrument Trays	American Healthcare Supply Co., Inc.	KDD	Class I	1993-06-01
K923033	The Tracker	Epm Information Systems, Inc.	LXJ	Class II	1993-06-01
K921263	Sunlite Laryngoscope	Sunmed, Inc.	CCW	Class I	1993-06-01
K921208	Accu-Beam Tube Set	Tti Medical	GCJ	Class II	1993-06-01
K931742	Inject-R Fill	Union Broach, Div. Moyco Industries, Inc.	EKM	Class I	1993-05-27
K931386	Hemashield Microvel/woven Double Velour Fabric	Meadox Medicals, Div. Boston Scientific Corp.	DXZ	Class II	1993-05-27
K931162	King-Hue, Royal Coral, Super-C Artificial Teeth	King Dental Corp.	ELM	Class II	1993-05-27
K931102	Cordis Nihon Catheter Sheath Introducer	Cordis US Corp.	DYB	Class II	1993-05-27
K931096	Duraflor	Pharmascience, Inc.	LBH	Class II	1993-05-27
K931087	Cleancuff(tm)	Med-Con, Inc.	DXQ	Class II	1993-05-27
K931084	Tempit	Centrix, Inc.	EMA	Class II	1993-05-27
K930764	Endo-Ice-Pulp Tester-Thermal	The Hygenic Company, LLC	EAT	Class II	1993-05-27
K930504	New Dentin Primer	Dentsply Intl.	KLE	Class II	1993-05-27
K930453	Singles	Nexadental	ECI	Class I	1993-05-27
K930202	Titan Separating Spring	Ortho Spectrum, Inc.	DZC	Class I	1993-05-27
K926347	Duceranium U	Degussa AG	EJH	Class II	1993-05-27
K926340	New Lead Introducer Kits, Various Models	Telectronics Pacing Systems, Inc.	DYB	Class II	1993-05-27
K926147	Gold-Platinum Based Casting Alloy	Jeneric/Pentron, Inc.	EJS	Class II	1993-05-27
K926146	Bio C & B	Jeneric/Pentron, Inc.	EJS	Class II	1993-05-27
K925979	Dual Lumen L-Cath Catheter System	Luther Medical Products, Inc.	DQX	Class II	1993-05-27
K925331	Correct and Correct Fit II	Jeneric/Pentron, Inc.	EJS	Class II	1993-05-27
K925163	Micodose Chlorhexiprep	Unicep	ECM	Class I	1993-05-27
K925123	Atrium's Hybrid PTFE	Atrium Medical Corporation	DSY	Class II	1993-05-27
K924971	Forestadent Brackets	Forestadent Bernhard Forster GmbH	EJF	Class I	1993-05-27
K924754	Dermagran Wound Dressing	Derma Sciences, Inc.	FRO	Unclassified	1993-05-27
K924234	Cons. Current Periph. Nerve Loc. Ns232,ns262,ns272	Fisher & Paykel Electronics, Ltd.	KOI	Class II	1993-05-27
K924190	Iss O-Ring Attachment	Implant Support Systems, Inc.	DZE	Class II	1993-05-27
K923980	Q3 Disposable Prophy Angle	Q3 Special Products, Inc.	EGS	Class I	1993-05-27
K923538	Mon-a-Therm Foley Kit	Mallinckrodt Medical	FCM	Class II	1993-05-27
K923496	Urinary Care Supplies	Orion Life Systems, Inc.	KNY	Class II	1993-05-27
K922985	Clean Up	Bio-Probe, Inc.	EIA	Class I	1993-05-27
K921979	Root Zx	J. Morita USA, Inc.	LQY	Unclassified	1993-05-27
K915699	Nellcor Portable Pulse Oximeter Model N-20	Nellcor, Inc.	DQA	Class II	1993-05-27
K931493	Kodak Ektachem Total Iron-Binding Capacity Kit	Eastman Kodak Company	JMO	Class I	1993-05-26