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 2241 of 3531

510(k) clearances, page 2241 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932600	Modified Site Power Handpiece II	Chiron Vision Corp.	EKX	Class I	1994-01-25
K932111	Dental X-Ray Unit	Castellini S.p.A.	EHD	Class II	1994-01-25
K931844	Custom Procedure Medical Tray or Kit	Custom Medical Products, Ltd.	LRO	Class II	1994-01-25
K931759	Carapace Sterile Gauze Trays	Carapace, Inc.	LRO	Class II	1994-01-25
K931670	Carapace Epidural Block & Spinal Myelogram Trays	Carapace, Inc.	CAZ	Class II	1994-01-25
K931357	Aod4000 Disposable Pak	American Optical Corp.	HQC	Class II	1994-01-25
K931054	Trick Modular Knee Tibial Tray-Porous	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1994-01-25
K930708	Philips Gyroscan T5 II Release 3	Philips North America LLC	LNH	Class II	1994-01-25
K930518	Talia Laser Slit	Talia Technology, Ltd.	HJO	Class II	1994-01-25
K930457	Medimac Bandage	Enquay Pharmaceutical	KGX	Class I	1994-01-25
K930174	Glasses Molasses	Arthur F. Kozakowski, Jr.	HQZ	Class I	1994-01-25
K925210	90Dx Multitest Meter, Modification	Mesa Medical, Inc.	FLB	Class II	1994-01-25
K924340	P.f.c. Mod Total Knee/condyl 3 Fem Comp Tib Insert	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1994-01-25
K923516	Compound Benzoin Tincture Usp Sepp	Medi-Flex Hospital Products, Inc.	KMF	Class I	1994-01-25
K920399	Compound Benzoin Tincture Usp Frepp	Medi-Flex Hospital Products, Inc.	KMF	Class I	1994-01-25
K935872	Namtai	Nam Tai Electronics (Canada), Ltd.	DXN	Class II	1994-01-24
K935854	Ultraviolet Lamps for Tanning	Cosmedico Light, Inc.	LEJ	Class II	1994-01-24
K935766	Primary African Green Monkey Kidney Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-01-24
K935288	Synelisa Cardiolipin Antibodies	Elias U.S.A., Inc.	MID	Class II	1994-01-24
K934818	Hand Held Dental X-Ray Device	Dept. of the Army	IZL	Class II	1994-01-24
K934742	Swan-Ganz Continuous Cardiac Output/oximetry/venous Port	Baxter Healthcare Corporation	DYG	Class II	1994-01-24
K934140	Mr290 Humidification Chamber Single Use	Fisher & Paykel Electronics, Ltd.	BTT	Class II	1994-01-24
K933535	Ventstream Drug Nebulizer	Medic-Aid, Ltd.	CAF	Class II	1994-01-24
K933097	Sound Selector Full-Service Audiometer	Ensoniq Corp.	EWO	Class II	1994-01-24
K932781	Dual Valved Respiratory T	Innovations for Mechanical Ventilation, Inc.	CAI	Class I	1994-01-24
K932780	Male/male Luer Transfer Tubing	Innovations for Mechanical Ventilation, Inc.	CAI	Class I	1994-01-24
K932607	Cobas(r) Core Ft4 Eia	Roche Diagnostic Systems, Inc.	CEC	Class II	1994-01-24
K932605	Cobas (R) Core T4 Eia	Roche Diagnostic Systems, Inc.	KLI	Class II	1994-01-24
K931606	7-510-25 Hysteromed Tubing Kit	Nortech	HIG	Class II	1994-01-24
K930574	Aerochamber W/mask, Modified	Monaghan Medical Corp.	CAF	Class II	1994-01-24
K935727	P&fs Pit and Fissure Sealant	Jedental Co., Inc.	EBC	Class II	1994-01-21
K935714	Crystalline L3 Multi-Use Hybrid Composite	Confi-Dental Products Co.	DYH	Class II	1994-01-21
K935689	Ionosit Base Liner	Foremost Dental Mfg., Inc.	EBD	Class II	1994-01-21
K935601	0.22 Micron Final Filter with Extension Tube	Puritas Health Care, Inc.	FPA	Class II	1994-01-21
K935567	Sodem Power System	Sodemsystems	HWE	Class I	1994-01-21
K935341	Comfort Plus Breast Shells	Marshall Baby Products	HFS	Class I	1994-01-21
K935340	Comfort Plus Nipple Shields	Marshall Baby Products	HFS	Class I	1994-01-21
K935335	Nu.ear Ss-10 in the Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935334	Nu.ear Sd-1 in the Ear (Ite) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935333	Nu.ear Ss-1 in the Ear (Ite) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935332	Nu.ear Ae-1 in the Ear (Ite) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935331	Nu.ear Sd-3 in the Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935330	Nu.ear Ss-3 in the Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935329	Nu.ear Ae-2 in the Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935328	Nu.ear Ss-2 in the Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935327	Nu.ear Sd-2 in-the-Canal (Itc) Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935326	Nu-Ear Sd-10 in the Canal Hearing Aid	Nu-Ear Electronics	ESD	Class I	1994-01-21
K935250	Accu-Path	Cox Medical Ent., Inc.	FCL	Class I	1994-01-21
K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve	Merit Medical Systems, Inc.	DYB	Class II	1994-01-21
K934845	Sonicator 715	Mettler Electronics Corp	IMG	Class II	1994-01-21