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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3268 of 3528

510(k) clearances, page 3268 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812666	Thyroxine (T4) 125I	Pcl-Ria, Inc.	CDP	Class II	1981-10-02
K812664	Aca Immunoglobulin G Analytical Test	E.I. Dupont de Nemours & Co., Inc.	DEW	Class II	1981-10-02
K812647	Emit Auto Carousel	Syva Co.	JQW	Class I	1981-10-02
K812641	Uric Acid Reagent-Enzymatic-Color-520 Nm	Reagents Applications, Inc.	KNK	Class I	1981-10-02
K812640	Ure Sil Embolectomy/thrombectomy Cath	Uresil, LLC	DXE	Class II	1981-10-02
K812639	Unicuff	Frontier Products	DXP	Class II	1981-10-02
K812635	Anemia Control	Environmental Chemical Specialties	JJY	Class I	1981-10-02
K812618	Assure Natural Fit Tampon	Personal Products Co.	HIL	Class II	1981-10-02
K812617	Vitrogen Tm 100	Collagen Corp.	KIT	Class I	1981-10-02
K812611	Quanticoat Neonatal 125 T4 Radioimmuno	Kallestad Laboratories, Inc.	CDP	Class II	1981-10-02
K812609	Vasculab #Vsc21	Medasonics, Inc.	JOM	Class II	1981-10-02
K812608	Vasculab #R12b	Medasonics, Inc.	DSF	Class I	1981-10-02
K812607	Tenckhoff Peritoneal Catheters	Quinton, Inc.	FJS	Class II	1981-10-02
K812605	Fiber Optic Light Source I	Venture Technology, Inc.	EAY	Class I	1981-10-02
K812604	Biovation Urinalysis Reporter	Biovation, Inc.	JQP	Class I	1981-10-02
K812601	Sqc Buffer	Transidyne General Corp.	JJS	Class I	1981-10-02
K812594	Ultra Zyme Plus Amyl #64982 & 65031	Harleco	CIJ	Class II	1981-10-02
K812593	Ultra Zyme Plus Ck-1 #64978, 65027 & 28	Harleco	CGS	Class II	1981-10-02
K812578	Elegance	Qualitone	ESD	Class I	1981-10-02
K812570	Labcer Fibrinogen Assay Kit & Calibr.	Sherwood Medical Co.	KQJ	Class II	1981-10-02
K812562	Surgical Retractor & Elastic Stays, Disp	Humboldt Products	GDG	Class I	1981-10-02
K812525	Mezlocillin 75 Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1981-10-02
K812521	Suntanning Device (Separ. from K812225)	Klafs Sunlight Corp.	FTC	Class II	1981-10-02
K812516	Surgical Blades & Scapels (Smpl. W/510k)	Needle Industries(Usa), Inc.	GES	Class I	1981-10-02
K812515	Cardiac Review Station	Diasonics, Inc.	DXG	Class II	1981-10-02
K812501	Opraflex	Selomas, Inc.	FRO	Unclassified	1981-10-02
K812448	Uni-Thane	Unicare Systems, Inc.	KKX	Class II	1981-10-02
K812424	Ci-Trol Heparin Controls, Low/high	American Dade	KFF	Class II	1981-10-02
K812410	Deltascan 2060 CT Scanner	Technicare Corp.	JAK	Class II	1981-10-02
K812400	Omnimedical Quad I	Omnimedical	JAK	Class II	1981-10-02
K812337	Isocentric Neutron Therapy Systems	The Cyclotron Corp.	IWL	Class II	1981-10-02
K812286	Miniteck Enteric Broth & Enterobacter	BD Becton Dickinson Vacutainer Systems Preanalytic	JSS	Class I	1981-10-02
K812124	Mla Electra 700	Medical Laboratory Automation Systems, Inc.	JPA	Class II	1981-10-02
K812019	Loxley Emergency Cervical Collar	Loxley Medical	IQK	Class I	1981-10-02
K811867	Sr-Algicap	J. Aderer, Inc.	ELW	Class II	1981-10-02
K812685	Ericka Neg. Pressure Arterial Blood Line	Ericka	FJK	Class II	1981-09-29
K812668	Afb Stain Set	Carr-Scarborough Microbiologicals, Inc.	JTS	Class I	1981-09-29
K812662	Immunogl. Fract. of Rabbit Antis./lambda	Dako Corp.	DEH	Class II	1981-09-29
K812661	Immunogl. Fract. of Rabbit Antis./kappa	Dako Corp.	DFH	Class II	1981-09-29
K812658	Cea Control Plasma	Pacific Hemostasis	DHX	Class II	1981-09-29
K812648	Ehtox Gastric Lavage Kit #2050 & #2070	Ethox Corp.	KNT	Class II	1981-09-29
K812633	Aca Immunoglobulin A/m Calibrators	E.I. Dupont de Nemours & Co., Inc.	CZP	Class II	1981-09-29
K812632	Aca Immunoglobin M Test Pack	E.I. Dupont de Nemours & Co., Inc.	DFT	Class II	1981-09-29
K812631	Aca Immunoglobin a Test Pack	E.I. Dupont de Nemours & Co., Inc.	CZP	Class II	1981-09-29
K812630	Aca Immunoglobulin G Calibrator	E.I. Dupont de Nemours & Co., Inc.	DEW	Class II	1981-09-29
K812625	Aca Plasminogen Test Pack	E.I. Dupont de Nemours & Co., Inc.	DDX	Class I	1981-09-29
K812602	Rabbit Coagulase Plasma	Dutchland Laboratories, Inc.	JTL	Class I	1981-09-29
K812596	Ultra Zyme Plus Alp #64962, 65029 & 30	Harleco	CJE	Class II	1981-09-29
K812595	Ultra Chem E-Glu #64976 & 65040	Harleco	CFR	Class II	1981-09-29
K812558	Tissue-Tek III Accu-Cut Rotary Microtome	Miles Laboratories, Inc.	IDO	Class I	1981-09-29