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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3509 of 3526

510(k) clearances, page 3509 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760654	Multi-Ported Face Plate	Pilling Co.			1976-12-06
K760653	Adapter/standard Fiber Optics Light	Pilling Co.	EQH	Class I	1976-12-06
K760647	Adapter, Fiber Optics Headlight	Pilling Co.	FCW	Class II	1976-12-06
K760619	Radio Immuno Assay Kit/	New England Nuclear	CDD	Class II	1976-12-06
K760273	Lithotrite	V. Mueller O.V. Baxter Healthcare Corp.	FGK	Class II	1976-12-06
K761135	Short Inflated Rolls	Fred Sammons, Inc.	ION	Class I	1976-12-02
K761134	Plastic Finger Cuffs	Fred Sammons, Inc.	ILH	Class I	1976-12-02
K761133	Aesthesiometer	Fred Sammons, Inc.	GXB	Class I	1976-12-02
K761132	Tuning Fork	Fred Sammons, Inc.	GWX	Class I	1976-12-02
K761131	Safety Pin Splint	Fred Sammons, Inc.	ILH	Class I	1976-12-02
K761130	Bathtub Rails	Fred Sammons, Inc.	ILS	Class I	1976-12-02
K761129	Contoured Raised Toilet Seat	Fred Sammons, Inc.	ILS	Class I	1976-12-02
K761128	Lateral Trunk Supports	Fred Sammons, Inc.	IPT	Class I	1976-12-02
K761127	Long Handled Bath Brush	Fred Sammons, Inc.	ILS	Class I	1976-12-02
K761126	Extra Large Long Handled Sponge	Fred Sammons, Inc.	ILS	Class I	1976-12-02
K761125	Long Handled Sponge	Fred Sammons, Inc.	ILS	Class I	1976-12-02
K761124	Weed Puller & Pruner	Fred Sammons, Inc.	IKW	Class I	1976-12-02
K761123	Electric Razor Holder	Fred Sammons, Inc.	ILW	Class I	1976-12-02
K761122	Pruning Scissors	Fred Sammons, Inc.	IKW	Class I	1976-12-02
K761121	Electric Vibrator	Fred Sammons, Inc.	IRO	Class I	1976-12-02
K761120	Spin-a-Pull	Fred Sammons, Inc.	ION	Class I	1976-12-02
K761119	Sheet Metal Clamp	Fred Sammons, Inc.	IOD	Class I	1976-12-02
K761118	Hand Screw Clamp	Fred Sammons, Inc.	IOD	Class I	1976-12-02
K761117	Keyboard Sheilds	Fred Sammons, Inc.	ILP	Class I	1976-12-02
K761116	Breath Control Game	Fred Sammons, Inc.	ILT	Class I	1976-12-02
K761115	Rolling Pin	Fred Sammons, Inc.	IKW	Class I	1976-12-02
K761114	Foam Slippers	Fred Sammons, Inc.	IPM	Class I	1976-12-02
K761113	Built-Up Handle Utensils	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761112	Plastic Hand Cone	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761111	Square Food Guard	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761110	Bed Tray	Fred Sammons, Inc.	KMN	Class I	1976-12-02
K761109	Terrycloth Bibs	Fred Sammons, Inc.	KME	Class I	1976-12-02
K761108	Plastic Disposable Bib	Fred Sammons, Inc.	KME	Class I	1976-12-02
K761107	Food Guards	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761106	Weighted Fork	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761105	Weighted Spork	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761104	Adult Swivel Fork	Fred Sammons, Inc.	ILC	Class I	1976-12-02
K761103	Widex Hearing Aid Model F7h & F7t	Widex Hearing Aid Co., Inc.	ESD	Class I	1976-12-02
K761102	Ney-Lite	Deringer-Ney, Inc.			1976-12-02
K761101	Ney Vibrator	Deringer-Ney, Inc.			1976-12-02
K761094	Uva Phototherapy System	Dermatron Corp.	KGL	Class II	1976-12-02
K761090	Diagnostic Method-8-Glutamyltransferase	Technicon Instruments Corp.	JQB	Class I	1976-12-02
K761072	P.s.m. Justa Cover	The Owenby Co.	FXP	Class I	1976-12-02
K761063	Gammacord II Calculator Interface	Miles Laboratories, Inc.	JQP	Class I	1976-12-02
K761059	Male Urinary Catheter, External	Intermed, Inc.	KOD	Class II	1976-12-02
K761039	Urinary Leg Bag Drainage Tube	Pharmaseal Div., Baxter Healthcare Corp.	KNX	Class II	1976-12-02
K761011	Castle Tec-Test Aeration Monitor	Castle Co.	JOJ	Class II	1976-12-02
K760912	Dressing Change Kit	American Hospital Supply	KGO	Class I	1976-12-02
K760878	Bongort Ileostomy Pouch	Howmedica Corp.	EXB	Class I	1976-12-02
K760782	Tecnol Patient Use Ice Pack	Tecnol New Jersey Wound Care, Inc.	ILO	Class II	1976-12-02