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 2026-10-05, 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 3511 of 3526

510(k) clearances, page 3511 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760724	Peritoneal Dialysis System	Physio Control, Inc.	EKX	Class I	1976-11-23
K760708	Silastic Brand Q7-2091 Gastric Sump Tube	Dow Corning Corp. Healthcare Industries Materials	KNT	Class II	1976-11-23
K760592	Minicon Concentrator	Amicon, Inc.	JJH	Class I	1976-11-23
K760572	Seralute	Miles Laboratories, Inc.	CDX	Class II	1976-11-23
K761024	Racestyptine Rings	Septodont	EIG	Class I	1976-11-19
K760999	Thermograph, Medical	Honeywell, Inc.	IYM	Class III	1976-11-19
K760998	Endotrachael Tube and Holder	Mcgaw Respiratory Therapy	BTR	Class II	1976-11-19
K760960	Surgical Wire Driver	American Safety Equipment Corp.	DZJ	Class II	1976-11-19
K760956	Surgical Micro Drill	American Safety Equipment Corp.	DZA	Class I	1976-11-19
K760955	Phadebas T4 Ria	Pharmacia, Inc.			1976-11-19
K760936	Emit Amphetamine Confirmation Reagent	Syva Co.	DKZ	Class II	1976-11-19
K760935	Winged Fistula Needle	Gambro, Inc.	KOC	Class II	1976-11-19
K760929	Accutorq II	Ritter GmbH	EFB	Class I	1976-11-19
K760923	Humidifier-Cascade II	Medtronic, Inc.	BTT	Class II	1976-11-19
K760922	Perfusion Tubing Set	Shiley, Inc.	KDL	Class II	1976-11-19
K760908	Miniature Ascending Paper Chromato-	Ackerman Nuclear, Inc.	DPA	Class I	1976-11-19
K760905	Supermax Automatic X-Ray Processor	General Electric Co.	IXW	Class II	1976-11-19
K760883	Digi-Tab-Ria Digoxin Radiommunoassay	Nuclear Medical Laboratories, Inc.	DPB	Class II	1976-11-19
K760882	Ge Ct/t Model No. B7800 a	Arnold & Porter for G.E. Co.	JAK	Class II	1976-11-19
K760815	Fitting/dialyzer	Cobe Laboratories, Inc.	FTG	Class II	1976-11-19
K760797	Spiraflo Dialyzer, Disposable	Bentley Laboratories, Inc.	EJT	Class II	1976-11-19
K760702	Eri-Flo 900 Dialyzer	Erika, Inc.	FHS	Class II	1976-11-19
K760614	Peripheral Nerve Stimulator	Output, Inc.	BXN	Class II	1976-11-19
K760255	Test System, Thyroid Stim. Hormone Assay	Corning Medical & Scientific	JLW	Class II	1976-11-19
K760963	Decubitus Mattress	Arco Medical Products Co.	IKY	Class I	1976-11-18
K761019	Pipetter-Diluter (Model 273)	Beckman Instruments, Inc.	JRW	Class I	1976-11-16
K761013	Spinette Centrifuge	Damon Corp.	JQC	Class I	1976-11-16
K760996	Hearing Aid (Model 695D, 905 & 960P)	Unitron Industries, Inc.	ESD	Class I	1976-11-16
K760991	Surgine Face Mask	Surgikos, Inc.	FXX	Class II	1976-11-16
K760990	Inorganic Phosphorous Reagent	Worthington Biochemical Corp.	CEO	Class I	1976-11-16
K760977	Charnley Femur Drill #1 and #2	Cerenovus, Inc.	HWE	Class I	1976-11-16
K760976	Charnley Revision Set	Cerenovus, Inc.	JDG	Class II	1976-11-16
K760974	Charnley Femoral Component	Cerenovus, Inc.	JDG	Class II	1976-11-16
K760958	Surgical Oscillating Saw	American Safety Equipment Corp.	DZH	Class II	1976-11-16
K760953	Deep Freeze System (Dfs-30)	Spembly Medical, Ltd.	GEH	Class II	1976-11-16
K760939	Cortisol Reagent System	Beckman Instruments, Inc.	CGR	Class II	1976-11-16
K760919	Model 2106 Feta Sonde Fetal Monitor	Roche Medical Electronics, Inc.	HGM	Class II	1976-11-16
K760916	Las-R Human Alpha, Antitrypsin Test	Hyland Therapeutic Div., Travenol Laboratories	DEM	Class II	1976-11-16
K760900	Gamma Scintillation Counter	Beckman Instruments, Inc.	JJJ	Class I	1976-11-16
K760889	Test for Detection of Antirubella Antib	Abbott Medical	GOL	Class II	1976-11-16
K760839	Vaspar, Sealant for Fermentations	I M, Inc.			1976-11-16
K760838	Lacto-Phenol Cotton Blue Mounting Fl.	I M, Inc.	LEB	Class I	1976-11-16
K760837	Potassium Hydroxide W/glycerol Mtg Fl.	I M, Inc.			1976-11-16
K760825	Fungal Immunodiffusion Kit	I M, Inc.			1976-11-16
K760789	Ph Meter-130 (.001 Ph)	Corning Medical & Scientific	JQY	Class I	1976-11-16
K760788	Ph Meter-125 (.01 Ph)	Corning Medical & Scientific	JQY	Class I	1976-11-16
K760780	Double-Ended Needle	Travenol Laboratories, S.A.	FMI	Class II	1976-11-16
K760739	Aca Data Mate Accessory	E.I. Dupont de Nemours & Co., Inc.	JQP	Class I	1976-11-16
K760701	Sulfacytine 0.25 Mg.	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1976-11-16
K761017	Pressure Module (Model P3)	Datascope Corp.	DRQ	Class II	1976-11-15