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 3373 of 3526

510(k) clearances, page 3373 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792426	Disposable Temperature Probe	Hospitak, Inc.	FLK	Class II	1980-01-16
K792419	C-Dak 2100 Artificial Kidney	Cordis US Corp.	FJI	Class II	1980-01-16
K792407	Elvi-Aminolevulinic Acid	Volu Sol Medical Industries	DIJ	Class II	1980-01-16
K792350	Centria Lh Ria	Union Carbide Corp.	CEP	Class I	1980-01-16
K792333	Baker Intestinal Tube, Twin Cuff	Intl. Hospital Products, Inc.	KNT	Class II	1980-01-16
K792277	Model 7620 Line Clamp	B-D Drake Willock	KOC	Class II	1980-01-16
K792228	Vented i.v. Set	Abbott Medical	FPA	Class II	1980-01-16
K792137	Sorb System Urs	bioMerieux, Inc.	FKT	Class II	1980-01-16
K792136	Hypo-Allergenic Plastic Tape	National Patent Development Corp.	FPX	Class I	1980-01-16
K792128	Sterile Extension Tubes Indiv. Pkg.	Tronomed, Inc.	FMG	Class II	1980-01-16
K792127	Plas. Stck. W/extension Tube/sterile	Tronomed, Inc.	FMG	Class II	1980-01-16
K792126	3&4 Way Plastic Sterile Stpcks. Pkg.	Tronomed, Inc.	FMG	Class II	1980-01-16
K792125	3&4 Way Plastic Stopcocks, Nonsterile	Tronomed, Inc.	FMG	Class II	1980-01-16
K792124	Tandem Assembled 3&4 Way Stopcocks	Tronomed, Inc.	FMG	Class II	1980-01-16
K792116	Ysi Series 500 Thermistor Probes	Yellow Springs Instrument Co., Inc.	FLL	Class II	1980-01-16
K792007	Csf-Ventricular Catheter, Standard Des	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1980-01-16
K792005	Csf-Cardiac/peritoneal Catheter	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1980-01-16
K791996	Multiple Auto Antibody Test	Meda Stat Diagnostics, Inc.	DBL	Class II	1980-01-16
K791714	Surgifeed	Health Development Corp.	KNT	Class II	1980-01-16
K800030	Implantable Bipolar Cardiac Pulse Gen.	Telectronics, Inc.	DXY	Class III	1980-01-11
K792673	Cam-10 Cuirass Shell	Lifecare Services, Inc.	BYT	Class II	1980-01-11
K792640	Fluoromatic Phenytoin Fia	Bio-Rad	DLP	Class II	1980-01-11
K792637	Centria-Set Type D(anti-Sheep/goat)	Union Carbide Corp.	KTS	Class II	1980-01-11
K792636	Centria Radioimmunoassay Separation	Union Carbide Corp.	KTS	Class II	1980-01-11
K792633	Sterilization Process/outerwrap	Procter & Gamble Mfg. Co.	KET	Class I	1980-01-11
K792630	Sterilization Process/x-Ray Detect. Spg	Procter & Gamble Mfg. Co.	GDY	Class I	1980-01-11
K792629	Sterilization Process/t-Binder	Procter & Gamble Mfg. Co.	KMO	Class I	1980-01-11
K792628	Sterilization Process/vaginal Sponge	Procter & Gamble Mfg. Co.	EFQ	Unclassified	1980-01-11
K792624	Sterilization Process/ Mayo Pad	Procter & Gamble Mfg. Co.	JOJ	Class II	1980-01-11
K792623	Sterilization Process/absorbent Towel	Procter & Gamble Mfg. Co.	KKX	Class II	1980-01-11
K792622	Sterilization Process /Use Gowns	Procter & Gamble Mfg. Co.	FYA	Class II	1980-01-11
K792621	Sterilization Process Change Boundary	Procter & Gamble Mfg. Co.	KKX	Class II	1980-01-11
K792592	Ambu Universal Suction Pump	Narco Air-Shields	JCX	Class II	1980-01-11
K792588	Territin Ria Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	JMG	Class II	1980-01-11
K792579	Culturia Macconkey/columbia Cna	Clinical Convenience Products, Inc.	JXA	Class I	1980-01-11
K792563	Thrombokinetic Fibrinogen Assay	Bio/Data Corp.	KQJ	Class II	1980-01-11
K792533	Creatine Phosphokinase (Cpk) Reagent Set	Macomb Chemical Co.	JHW	Class II	1980-01-11
K792532	Glucose (Hexokinase) Reagent Set	Macomb Chemical Co.	CFR	Class II	1980-01-11
K792531	Sandare Chloride Procedure	Sandare Chemical Co., Inc.	CHJ	Class II	1980-01-11
K792509	Aca High Density Lipoprotein Choles.	E.I. Dupont de Nemours & Co., Inc.	CHH	Class I	1980-01-11
K792482	Chemistry Analyzer Reagents	Laboratory Products, Inc.	CIX	Class II	1980-01-11
K792135	Dye Curve Evaluator	Sci-Pro, Inc.	DQK	Class II	1980-01-11
K792133	Rubelisa Test Kit	Microbiological Assoc.	GOK	Class II	1980-01-11
K792058	Enteric-Tek	Flow Laboratories, Inc.	JSS	Class I	1980-01-11
K792600	Model III Handswitch	Sara Dan, Inc.	GEI	Class II	1980-01-10
K791923	Scleral Powder	Ocularists, Ltd.	HQH	Class I	1980-01-10
K792678	Cardiac Output Computer, M-Mlc-4100	Nihon Kohden America Inc	DXG	Class II	1980-01-09
K792663	Flexi-Cup Implant	Impladent, Ltd.	DZE	Class II	1980-01-09
K792659	Feedback Edr System Model Me-1	Bio-Feedback Systems, Inc.	HCC	Class II	1980-01-09
K792618	Tracheotomy Sponge, Non-Woven Delnet	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-09