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 3476 of 3526

510(k) clearances, page 3476 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771268	Infusion Set Type J	Berman, Pcp & Consultants, Inc.	FPA	Class II	1977-09-12
K771267	Infusion Set Type S	Berman, Pcp & Consultants, Inc.	FPA	Class II	1977-09-12
K771244	2,2Dimethoxy-2-Phenylacetophenone	Solar Laboratories, Inc.			1977-09-12
K771212	Safeed Disp. Plastic Catheter	Terumo America, Inc.	KNY	Class II	1977-09-12
K771049	Endoscopic Tray	American Hospital Supply	MMO	Class I	1977-09-12
K771004	Amhs Blood Analy. Triglyceoides Reag. Ki	Miles Laboratories, Inc.	CDT	Class I	1977-09-12
K770986	Flexi-Therm Film	E-Z-EM, Inc	KXZ	Class III	1977-09-12
K770956	Pas Anti-Embolism System	Hamilton Industries, Inc.	JOW	Class II	1977-09-12
K771561	Dover Urine Meter	Will Ross Co.	EXR	Class II	1977-09-07
K771654	Nimeticap	Espe GmbH (US)	EBF	Class II	1977-09-06
K771624	Cope Lung Forceps #305-218	J. Jamner Surgical Instruments, Inc.	GEN	Class I	1977-09-06
K771611	Protector	Richard-Allan Medical Ind., Inc.	MMK	Class II	1977-09-06
K771575	Electronic Eiplator Model No. 101	Electronic Depilatory, Inc.	KCX	Class I	1977-09-06
K771537	Aquamatic K-Module Model K-20	Gorman Rupp Industries	DWJ	Class II	1977-09-06
K771531	Laparotomy Sponges	Surgilite Intl., Inc.	EFQ	Unclassified	1977-09-06
K771449	Arteoial Tonometer Ml-105	Nicolet Biomedical Instruments	DXN	Class II	1977-09-06
K771448	Sterile Suture Removal Kit	Premium Plastics, Inc.	KDD	Class I	1977-09-06
K771332	Patient Grounding Cables	Edward Weck, Inc.	GEI	Class II	1977-09-06
K771331	Conductive Electrode Gel	Edward Weck, Inc.	GEI	Class II	1977-09-06
K771330	Disp. Ground Plate	Edward Weck, Inc.	GEI	Class II	1977-09-06
K771329	Disp. Ground Pad Pregelled	Edward Weck, Inc.	GEI	Class II	1977-09-06
K771258	Blood Cell Separator 2997	Intl. Business Machines	GKT	Class II	1977-09-06
K771627	Permagum	Espe GmbH (US)	ELW	Class II	1977-09-02
K771617	Speci-Mix	Thermolyne Corp.	GLE	Class I	1977-09-02
K771616	Api 20A	Analytical Products, Inc.	JSP	Class I	1977-09-02
K771587	Instant Air	Hyde, Vernon E., D.D.S.	BWC	Class II	1977-09-02
K771583	Fluorescent Anti. Anti-Human C3	Burroughs Wellcome Co.	DAC	Class II	1977-09-02
K771580	Tektally II	Scientific Products	GKM	Class I	1977-09-02
K771578	Phadebas Rast Peniclloyl G/v Test	Pharmacia, Inc.	DHB	Class II	1977-09-02
K771554	Suture Retention Clamp	Concept, Inc.	KGS	Class I	1977-09-02
K771535	Las-R Human Crp Test	Hyland Therapeutic Div., Travenol Laboratories	DCN	Class II	1977-09-02
K771472	Multistat III Triglyceride Test	Instrumentation Laboratory Co.	CDT	Class I	1977-09-02
K771467	Multistat III Aspartate Aminotransferase	Instrumentation Laboratory Co.			1977-09-02
K771466	Multistat III Alanine Aminotransferase	Instrumentation Laboratory Co.	CKA	Class I	1977-09-02
K771465	Multistat III Lactic Dehydrogenase	Instrumentation Laboratory Co.	CFJ	Class II	1977-09-02
K771464	Multistat III Glucose Test	Instrumentation Laboratory Co.	CFR	Class II	1977-09-02
K771439	Pathonorm H & L	Nyegaard & Co. A/S	JJT	Class I	1977-09-02
K771438	Autonorm	Nyegaard & Co. A/S	JJT	Class I	1977-09-02
K771437	Seronorm Lipid	Nyegaard & Co. A/S	JJY	Class I	1977-09-02
K771436	Seronorm	Nyegaard & Co. A/S	JJT	Class I	1977-09-02
K771410	Rheumanosticon R	Organon LLC	DHR	Class II	1977-09-02
K771389	Ck-1 Ultrazyme Plus	Harleco	CGS	Class II	1977-09-02
K771388	Amylase Ultrazyme Plus	Harleco	JFJ	Class II	1977-09-02
K771382	Immunostat T3 Uptake Test	Meloy Laboratories, Inc.			1977-09-02
K771377	Thyrodot-4, Thyrodot-Sh	Medcom Diagnostics, Inc.	JLW	Class II	1977-09-02
K771324	3-(N-Morpholins)-Propane Sulfonic Acid	Corning Medical & Scientific	JHX	Class II	1977-09-02
K770993	Triglyceride Reagent Set	Macomb Chemical Co.	CDT	Class I	1977-09-02
K770933	Bio-Shield Csr Wrap	Convertors	FRG	Class II	1977-09-02
K770603	Hypronosticon Tm	Organon LLC	JMM	Class I	1977-09-02
K771615	Audi-Sil Earmold Material	Coe Laboratories, Inc.	ESH	Class II	1977-08-30