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 2516 of 3531

510(k) clearances, page 2516 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903573	Reflotron Creatinine Test Tabs	Boehringer Mannheim Corp.	JFY	Class II	1990-09-07
K903569	Curity Thoracentesis Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	JOL	Class II	1990-09-07
K903511	Synermed Total Protein Reagent Kit	Synermed, Inc.	CEK	Class II	1990-09-07
K903508	Labelling Changes to Impres-Mb-X	Intl. Immunoassay Laboratories, Inc.	JHW	Class II	1990-09-07
K903432	Imx Free T3 Calculation	Abbott Medical	CDP	Class II	1990-09-07
K903407	Affinity Hlh Test System	BD Becton Dickinson Vacutainer Systems Preanalytic	JJY	Class I	1990-09-07
K903338	Kenlor Therapeutic Drug Monitoring (Tdm) Control	Kenlor Industries, Inc.	JJY	Class I	1990-09-07
K903334	Urea Nitrogen Test	Em Diagnostic Systems, Inc.	CDQ	Class II	1990-09-07
K903311	Novapath Tsh Enzyme Immunoassay	Bio-Rad	JLW	Class II	1990-09-07
K903310	Challenge(tm) Brand Liq Multi-Analyte Linear Contr	Medical Analysis Systems, Inc.	JJY	Class I	1990-09-07
K903309	Roche Cobas Ready Amylase Reagent	Roche Diagnostic Systems, Inc.	JFJ	Class II	1990-09-07
K903204	Mrp-20: Suppl r/f Coil Hs/mr Quadrature Head Coil	Summit World Trade Corp.	LNH	Class II	1990-09-07
K902979	Milenia (Tm) Amphetamine	Siemens Healthcare Diagnostics Inc.	DKZ	Class II	1990-09-07
K902976	Medi Model Sbl502-B (Liss Body Stimulator) Zero Dc	Medical Consultants Intl., Ltd.	GZL	Class II	1990-09-07
K902834	Abbott Imx Free T4	Abbott Medical	CEC	Class II	1990-09-07
K902731	Endoscopic Hemostatic Ligating Loop	United States Surgical, A Division of Tyco Healthc	GAL	Class II	1990-09-07
K902561	Roche Cobas Ready Creatinine Reagent	Roche Diagnostic Systems, Inc.	CGX	Class II	1990-09-07
K902543	Acid Phosphotase Reagent Test and Kit	Crestat Diagnostics, Inc.	CKB	Class II	1990-09-07
K902382	C3c and C4 Rid Kits	The Binding Site	CZW	Class II	1990-09-07
K901866	Deguflex (R) Cs Light	Degussa AG	ELW	Class II	1990-09-07
K901687	F-24 Femoral Hip Prosthesis	Med-Tek Corp.	LWJ	Class II	1990-09-07
K901117	Ohmeda Universal Pac	GE Healthcare	BSZ	Class II	1990-09-07
K900425	Surgical Cotton Gloves	Allo Pro Corp.	LYU	Class I	1990-09-07
K895980	Sharghp Insulin Syringes	Shargh Pharmaceutical Co., Inc.	FMF	Class II	1990-09-07
K895812	Sharghp Intravenous Catheter	Shargh Pharmaceutical Co., Inc.	FOZ	Class II	1990-09-07
K895811	Sharghp Hypodermic Needle	Shargh Pharmaceutical Co., Inc.	FMI	Class II	1990-09-07
K895810	Sharghp Syringes, with and without Needle	Shargh Pharmaceutical Co., Inc.	FMF	Class II	1990-09-07
K903717	Dispensa-Lube	Gam-Med Packaging Corp.	KMJ	Class I	1990-09-06
K903677	Argident 2A Dental Gold Alloy for Poreclain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-06
K903549	Argenco 25	Argen Precious Metals, Inc.	EJT	Class II	1990-09-06
K903548	Argenco 9	Argen Precious Metals, Inc.	EJT	Class II	1990-09-06
K903536	Small Joint Instruments (Scissor Handle)	Leonard Medical, Inc.	LOS		1990-09-06
K903392	Electromedics Bt422-120 and Bt422-40	Electromedics, Inc.	CAC	Class II	1990-09-06
K903105	Olive K-Wires	Danek Medical, Inc.	JEC	Class II	1990-09-06
K903008	Vident 90 Alloy and Vident 95 Alloy	Vident	EJH	Class II	1990-09-06
K902915	Anti-Sci-70 Microassay	Diamedix Corp.	LJM	Class II	1990-09-06
K902911	Titanium/stainless Steel Instruments	Impla-Med	DZE	Class II	1990-09-06
K902893	Ti-Core (Dental Composite)	Medical Device Inspection Company	EBF	Class II	1990-09-06
K902838	Denture Dynamic's Denture Magic	Denture Dynamic'S, Inc.	EFT	Class I	1990-09-06
K902646	Hood Gear (Tm) Breakaway Headgear with Neck Strap	Ormco Corp.	DZB	Class II	1990-09-06
K902645	Hood Gear (Tm) Breakaway Headgear W/ High Pull	Ormco Corp.	DZB	Class II	1990-09-06
K902348	Surgical Gown, Polyultra(tm) Fabric System*	Futuristic Medical Concepts, Inc.	FYA	Class II	1990-09-06
K902319	Bauer Temno Biopsy Needle	Proact, Ltd.	FCG	Class II	1990-09-06
K902066	Disposable Biopsy Forcep for Flexible Endoscopes	Endo-Scientific, Inc.	KNW	Class II	1990-09-06
K901941	Luhr Mandibular Compression/reconstruction Plates	Howmedica Corp.	JEY	Class II	1990-09-06
K901940	Luhr Micro Mesh	Howmedica Corp.	JEY	Class II	1990-09-06
K901867	Deguflex (R) Cs Putty	Degussa AG	ELW	Class II	1990-09-06
K901865	Deguflex Monophase	Degussa AG	ELW	Class II	1990-09-06
K901580	Prophy Paste	Dentsply Intl.	EJR	Class I	1990-09-06
K904002	Genox Model CT-1 Oxygen/nitrogen Gener-Distr Syst	Pacific Consolidated Industries LLC	CAW	Class II	1990-09-05