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 2026-10-08, 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 3389 of 3526

510(k) clearances, page 3389 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790433	Naturdom	Juan C. Lucena	HIS	Class II	1979-10-04
K791918	Jelco Winged Intravascular Catheter	Jelco Laboratories	FOZ	Class II	1979-10-02
K791863	Mac Lee Enemad	Mac Lee Medical Products	FCE	Class I	1979-10-02
K791847	Aspri-Luke	Medical Marketing Group	BYZ	Class II	1979-10-02
K791846	Dispossable Suction Tube, 6 French	Dlp, Inc.	DTS	Class II	1979-10-02
K791844	Critiflo & Critiflo Dome	Gould, Inc.	KRA	Class II	1979-10-02
K791834	Nurite II Vrm Dual (Elec. Nerve Stim.)	Bio-Medical Systems Corp.	GZJ	Class II	1979-10-02
K791833	Nurite II Vrm Single (Elec. Nerve Stim)	Bio-Medical Systems Corp.	GZJ	Class II	1979-10-02
K791829	Shiley Quick Disconnect Assembly	Shiley, Inc.	KRI	Class I	1979-10-02
K791778	Medtronic Model 9410 Teletrace Receiver	Medtronic, Inc.	DXH	Class II	1979-10-02
K791776	Arrhythmia II Editor	Spacelabs, Inc.	DQK	Class II	1979-10-02
K791753	Ipag Micronova Interface #781111	Robinton Corp.	DXG	Class II	1979-10-02
K791748	Ultipor Blood Filter Extra-Corporeal	Pall Biomedical Products Co.	DTM	Class II	1979-10-02
K791738	Custom Dressing Change Trays	Sterile Design, Inc.	FMC	Class I	1979-10-02
K791645	Vickers Medical Model 112 Treonic Dc2	Vickers America Medical Corp.	FKW	Class II	1979-10-02
K791609	Be-Sure	Biologics Intl., Inc.	JHJ	Class II	1979-10-02
K791581	Coloplast Carbon Gas Filter	C.R. Bard Inc	EXB	Class I	1979-10-02
K791529	Infusion Needle Set	I.M.P. Group, Ltd.	FPA	Class II	1979-10-02
K791869	Glucose Oxidase (Frinder) Kit	Mid Tech, Inc.	CGA	Class II	1979-10-01
K791854	Centria Hpl Ria	Union Carbide Corp.	JMF	Class II	1979-10-01
K791853	Tee- Two-Way Valves M-500	Mem Medical, Inc.			1979-10-01
K791852	T-Pc for r.f. M.d., M-501	Mem Medical, Inc.			1979-10-01
K791851	Red Cap, M-502	Mem Medical, Inc.	BYX	Class I	1979-10-01
K791850	One-Way Valve-Female, M-503	Mem Medical, Inc.	CBP	Class II	1979-10-01
K791849	One-Way Valve-Male, M-504	Mem Medical, Inc.	CBP	Class II	1979-10-01
K791848	Respirometer Manifold M-505	Mem Medical, Inc.	BYX	Class I	1979-10-01
K791842	Motivator	Medtronic, Inc.	BWF	Class II	1979-10-01
K791839	H59 Critical Care Monitor	Medtel Pty., Ltd.	DSK	Class II	1979-10-01
K791838	Hsh/h512 Adult Physiological Monitors	Medtel Pty., Ltd.	DSK	Class II	1979-10-01
K791836	Quantimune Hfsh Ria	Bio-Rad	CGJ	Class I	1979-10-01
K791827	Ldh Clini Gel Kit	Clinical Sciences, Inc.	CFE	Class II	1979-10-01
K791826	Cpk Clini Gel Kit	Clinical Sciences, Inc.	JHT	Class II	1979-10-01
K791825	Ly-Pro-Trol #Acs-Lp101	Analytical Control Systems	JJY	Class I	1979-10-01
K791818	Mueller Hinton Medium W/sheep Blood	Isle Media and Sterile Products, Inc.	JTZ	Class II	1979-10-01
K791817	Mio Medium (Motility Indole Ornithine)	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-01
K791816	Dc Agar (Desoxycholate Citrate Agar)	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-10-01
K791814	Bile Esculin Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-01
K791813	Dnase Test Agar W/methyl Green	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-01
K791808	Cervi-Trac	Dr. K.G. Rude	ILZ	Class I	1979-10-01
K791805	Conphar Exam. Gloves, Polyethylene	Conphar, Inc.	FMC	Class I	1979-10-01
K791796	Additive Hinge Cap	Abbott Medical	KPE	Class II	1979-10-01
K791794	Factor VII Deficient Plasma	Sigma Chemical Co.	GGP	Class II	1979-10-01
K791787	Xylose Lysine Desoxycholate Agar Plate	American Laboratory Supply, Inc.	JSI	Class I	1979-10-01
K791785	Mektoen Enteric Agar 100X15mm Plate	American Laboratory Supply, Inc.	JSI	Class I	1979-10-01
K791764	Scoville-Lewis Aneurysm Clips	Cerenovus, Inc.	HCH	Class II	1979-10-01
K791757	Cervical Orthopedic Pillow	Adeline V. Santoro			1979-10-01
K791729	Syringe Infusion Pump	Princeton Medical Instruments, Inc.	FRN	Class II	1979-10-01
K791723	Quantaffirm Cpk ISO Enzyme Serum (Human)	Organon LLC	JJT	Class I	1979-10-01
K791700	Corti-Shure	Nuclear Medical Laboratories, Inc.	CGR	Class II	1979-10-01
K791698	Cdc Anaerobic Sheep Blood Agar (Ba)	Gibco Laboratories Life Technologies, Inc.	JSG	Class I	1979-10-01