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 2026-11-02, 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 2493 of 3531

510(k) clearances, page 2493 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904969	Hood, Operating, Surgical	Chicago Assoc. for Retarded Citizens	FXY	Class II	1990-12-12
K904667	Na Needles	Olympus Corp.	GDM	Class I	1990-12-12
K904566	New Cobe Centrysystem(tm) 100 Hg Dialyzer	Cobe Laboratories, Inc.	FJI	Class II	1990-12-12
K904488	Kaltostat Wound Dressing	Calgon Vestal Div.	QSY	Unclassified	1990-12-12
K904229	Multilase 60	Laser Photonics, Inc.	GEX	Class II	1990-12-12
K904227	Multilase 45	Laser Photonics, Inc.	GEX	Class II	1990-12-12
K903662	Peewee Replacement Gastrostomy Tube	Biosearch Medical Products, Inc.	KNT	Class II	1990-12-12
K905364	Round Staple	O'Tec Corp.	JDR	Class II	1990-12-11
K905363	Fixation Staple	O'Tec Corp.	JDR	Class II	1990-12-11
K905362	Barbed Square Staple	O'Tec Corp.	JDR	Class II	1990-12-11
K905352	Blade Plate	O'Tec Corp.	KTT	Class II	1990-12-11
K905349	Austin Moore Type Hip Prothesis	O'Tec Corp.	KWL	Class II	1990-12-11
K905348	Hansen-Street Type Intramedullary Nail	O'Tec Corp.	KTW	Class II	1990-12-11
K905346	Jewett Hip Nail	O'Tec Corp.	KTT	Class II	1990-12-11
K905345	K-Wire	O'Tec Corp.	HTY	Class II	1990-12-11
K905344	Knowles Pin	O'Tec Corp.	JDW	Class II	1990-12-11
K905342	Lag Screw	O'Tec Corp.	KTT	Class II	1990-12-11
K905341	Rush Pin	O'Tec Corp.	HTY	Class II	1990-12-11
K905338	Side Plate	O'Tec Corp.	KTT	Class II	1990-12-11
K905337	Steinman Pin	O'Tec Corp.	HTY	Class II	1990-12-11
K905336	Steinman Pin, Threaded	O'Tec Corp.	JDW	Class II	1990-12-11
K905334	Thompson Type Hip Prosthesis	O'Tec Corp.	KWL	Class II	1990-12-11
K905284	Hdl-Cholesterol Precipitant 7773/7573/7473/7173	Amresco, Inc.	LBR	Class I	1990-12-11
K905226	Triglyceride (Gpo) Reagent, Universal	Enzyme Technology, Inc.	JGY	Class I	1990-12-11
K905153	Remote Controlled X-Ray Diagnostic Rs-110	Shimadzu Medical Systems	IXR	Class II	1990-12-11
K905152	Remote Controlled X-Ray Diag. Rsz-200	Shimadzu Medical Systems	IXR	Class II	1990-12-11
K905005	Disposable Surgical Towel (Non-Sterile)	Marand Products, Inc.	KKX	Class II	1990-12-11
K904905	Doa Liquid Multi-Analyte Drugs of Abuse Controls	Medical Analysis Systems, Inc.	DIF	Class I	1990-12-11
K904436	Quickanchor (Tm)	Mitek Surgical Products, Inc.	GAS	Class II	1990-12-11
K904209	Simultest T & B Cell Test,anti-Leu-4 Fitc & 12 Pe	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1990-12-11
K904004	Amrescocreat Kinase Reagent 7716/17,7516,7416,7116	Amresco, Inc.	CGS	Class II	1990-12-11
K903151	Intervertebral Disc Rongeur	Von Zeppelin GmbH	HAE	Class II	1990-12-11
K902295	Osteograf/n Natural Hydroxylapatite, 40-60 Mesh	Ceramed Corp.	LYC	Class II	1990-12-11
K905228	Model Ca.150 Cellulose Acetate Hollow Fiber Dialyz	Baxter Healthcare Corporation	FJI	Class II	1990-12-10
K904476	Vessel Dilator	Datascope Corp.	DRE	Class II	1990-12-10
K904173	Insulated Electrodes and Laparoscopic Probics	Baxter Healthcare Corporation	HET	Class II	1990-12-10
K903489	Thera-Mist Tm Volumina Incent Spirometer, P40000	Pegasus Research Corp.	BWF	Class II	1990-12-10
K902775	Knight Sacral Screw	Danek Medical, Inc.	KWP	Class II	1990-12-10
K901005	Tsrh Spinal System (Add'l Sizes of Hooks)	Danek Medical, Inc.	KWP	Class II	1990-12-10
K905192	Diastat Anti-Sm/rnp	Shield Diagnostics, Ltd.	LKP	Class II	1990-12-07
K905191	Diastat Anti-Sm	Shield Diagnostics, Ltd.	LKP	Class II	1990-12-07
K905190	Diastat Ena Profile	Shield Diagnostics, Ltd.	LJM	Class II	1990-12-07
K904872	Hdl Cholesterol Control	Analytical Control Systems	JJY	Class I	1990-12-07
K904774	Inglat-O-Ball	Milex Products, Inc.	HHW	Class II	1990-12-07
K904730	Qualitone Ultra Canal Genesis	Qualitone	ESD	Class I	1990-12-07
K904724	Conquest Direct Filling Composite (Dfc)	Jeneric/Pentron, Inc.	KLE	Class II	1990-12-07
K904576	Hearing Aid, Unitron Model Um60-Uh	Unitron Industries, Inc.	ESD	Class I	1990-12-07
K904402	Nidek Inc. Model Ac-2000 Derm	Nidek, Inc.	GEX	Class II	1990-12-07
K904401	Battery-Powered Toothbrush	The B & F System, Inc.	JEQ	Class I	1990-12-07
K904361	Kleartex Latex Surgeons Gloves	Kleartex Sdn Bhd	KGO	Class I	1990-12-07