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 3447 of 3526

510(k) clearances, page 3447 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780610	Instrument Lubricant	Abco Dealers, Inc.			1978-05-31
K780356	Output Digital Display Module, Model 401	Output, Inc.	DSK	Class II	1978-05-31
K780826	Bilirubin Rapid Stat Kit	Pierce Chemical Co.	CIG	Class II	1978-05-26
K780825	Triglyceride C-37 Rapid Stat Kit	Pierce Chemical Co.	JGY	Class I	1978-05-26
K780768	Model 5621A Interface	Hewlett-Packard Co.	DQK	Class II	1978-05-26
K780762	Embolectomy Catheter, Extend. Shelf Life	Shiley, Inc.	DXE	Class II	1978-05-26
K780752	Prophylaxis Angle	Young Dental Manufacturing Co 1, LLC.	EGS	Class I	1978-05-26
K780747	Snap-Way	Northwest Orthodontics, Inc.	DZB	Class II	1978-05-26
K780722	Advanced Denture System	Advanced Marketing Research Co.	EKO	Class II	1978-05-26
K780711	Micro-Ring	Howmedica Corp.	EGG	Class I	1978-05-26
K780650	Flame Photometer, Model 455	Corning Medical & Scientific	JJO	Class I	1978-05-26
K780649	Flame Photometer, Model 435	Corning Medical & Scientific	JJO	Class I	1978-05-26
K780638	Accessory Hdl Cholesterol Reagent Set	The Dow Chemical Co.	CHH	Class I	1978-05-26
K780626	Venturi Oxygen Mask	Hospitak, Inc.	BYF	Class I	1978-05-26
K780624	Culdocentesis Tray	Cutter Laboratories, Inc.	GAA	Class I	1978-05-26
K780609	Mask, Isolation	Abco Dealers, Inc.	FXX	Class II	1978-05-26
K780568	Duran Flexible Ring	Hancock Laboratories, Inc.			1978-05-26
K780558	Bottle Breathing Device	B & F Medical Products, Inc.	BYO	Class I	1978-05-26
K780545	Sr-Plus Direct Cholesterol Test	Stanbio Laboratory	CGO	Class I	1978-05-26
K780543	Thermajust Circu-Temp	Techhnilab Instruments, Inc.	JRQ	Class I	1978-05-26
K780432	Arrhythmia Program Module	Midwest Analog & Digital, Inc.	DSI	Class II	1978-05-26
K780412	Total Iron Binding Capacity	Diagnostic Corp. of America	JQG	Class I	1978-05-26
K780360	Massager, Gum/ssage Powered Gum	Sunbeam Corp.	JEQ	Class I	1978-05-26
K780341	Scintillation, Liquid, Rackbeta	Lkb Instruments, Inc.	JJJ	Class I	1978-05-26
K780144	Dynex Blood Gas Quality Control Sys.	Analytical Products, Inc.	JJS	Class I	1978-05-26
K780587	Gynesurg	Polamedco, Inc.	KNA	Class II	1978-05-25
K780578	Sonograf Edp Real-Time Adapter	Foley, Lardner, Hollabaugh & Jacobs	IYO	Class II	1978-05-25
K780779	Econo-Float Water Flotation Mattress	Jefferson Industries, Inc.	IKY	Class I	1978-05-19
K780759	Model 902 Stand	Applied Medical Research	FSH	Class I	1978-05-19
K780758	Neurological Screening Stimulator M 3623	Medtronic, Inc.	GZB	Class II	1978-05-19
K780705	Infusion Pump-Model 2616	Harvard Apparatus, Inc.	FRN	Class II	1978-05-19
K780702	Css-60 Digital Heart Rate Meter	Burdick Corp.	DRT	Class II	1978-05-19
K780637	Hematology Slide Stainer	A. J. P. Scientific, Inc.	KPA	Class I	1978-05-19
K780635	Reagent Set Hdl Cholesterol	Boehringer Mannheim Corp.	CHH	Class I	1978-05-19
K780601	Airways	Abco Dealers, Inc.	CAE	Class I	1978-05-19
K780579	Subcupass Tunneling Tool	Medtronic, Inc.	HAO	Class I	1978-05-19
K780577	Platelets/cu Mm	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1978-05-19
K780576	125-I Labeled Human Luteinizing Hormone	Pcl-Ria, Inc.	CEP	Class I	1978-05-19
K780553	Comp. Clin. Chem. Ref. Serum-Benchmark	Beckman Instruments, Inc.	JIX	Class II	1978-05-19
K780552	Comp. Clin. Chem. Control Serum-Decision	Beckman Instruments, Inc.	JJY	Class I	1978-05-19
K780542	Alfatest	Panmed, Inc.	LBR	Class I	1978-05-19
K780541	Pressure Modules Models 1855 & 1856	Life-Tech Instruments, Inc.	IKN	Class II	1978-05-19
K780534	Urea Nitrogen (Enzymatic)	Macomb Chemical Co.	CDQ	Class II	1978-05-19
K780525	T-3 Uptake (Sorbent) Kit	Amersham Corp.	KHQ	Class II	1978-05-19
K780524	Ultrachem T-Bili 64971 Gilford 3500	Harleco	CIG	Class II	1978-05-19
K780523	Ultrachem Enzymatic Cholesterol 65025	Harleco	CHH	Class I	1978-05-19
K780515	Ultrachem E-Glu, 300 Series Centrifuchem	Harleco	CFR	Class II	1978-05-19
K780514	Ultrachem Creatinine 64972, Centrifuchem	Harleco	CGX	Class II	1978-05-19
K780513	Ultra Zyme Plus Amyl 64982, Gilford 3500	Harleco	CIJ	Class II	1978-05-19
K780501	Electrode Tester	Mg Medical Electronics	KRC	Class II	1978-05-19