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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2313 of 3531

510(k) clearances, page 2313 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930385	16 X 125 Mm Test Tube, Catalog #01-421	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930384	25 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-401	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930383	25 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-421	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930382	One Dramshell Vial, Catalog #02-421	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930381	One Dram Shell Vial, Catalog #02-441	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930380	16 X 125 Mm Test Tube, Catalog #01-261	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930379	One Dram Shell Vial, Catalog #02-281	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930378	25 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-441	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930377	25 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-461	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930376	One Dram Shell Vial, Catalog #02-211	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930375	16 X 125 Mm Test Tube, Catalog #01-211	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930374	25 Cm2, 75 Cm2, 150 Cm2, Flask, Catalog #03-111	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930373	One Dram Shell Vial, Catalog #02-111	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930372	16 X 125 Mm Test Tube, Catalog #01-311	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930371	16 X 125 Mm Test Tube, Catalog #01-321	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930370	One Dram Shell Vials, Catalog #02-311	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930369	25Cm, 75Cm, 150Cm, Flask, Catalog #03-311	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930368	One Dram Shell Vial, Catalog #02-321	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930367	25Cm2. 75Cm2, 150 Cm, Flask, Catalog #03-321	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930366	16 X 25 Mm Test Tube, Catalog #01-461	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930365	25Cm2, 75Cm2, 150Cm2 Flask, Catalog #03-241	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930364	One Dram Shell Vial, Catalog # 02-241	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930325	Cytoquant(tm) Mdck Canine Kidney Cells	Proteins Intl., Inc.	KIR	Class I	1993-03-23
K930130	Rheumelisa II Scl-70 Antibody Test Kit	Biowhittaker Molecular Applications, Inc.	LLL	Class II	1993-03-23
K926433	4.5F Imagecath(r) Coronary Angioscope, Cov45	Baxter Edwards	LYK	Class II	1993-03-23
K926423	S/2(tm) Stopcock	Psi Medical Products, Inc.	FGB	Class II	1993-03-23
K926421	Acs Et Hi-Flow/enhanced Torque Coronary Guid Cath	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1993-03-23
K925916	Vitek Rapid Call-Gram Positive Identification Card	Biomerieux Vitek, Inc.	LQL	Class I	1993-03-23
K925915	Vitek Rapid Call-Gram Negativ Ident Card	Biomerieux Vitek, Inc.	LQM	Class I	1993-03-23
K925523	Itc Bunji Platinum Embolization Coil	Interventional Therapeutics Corp.	HCG	Class II	1993-03-23
K925340	Coagulation Control Containing Hemoglobin	Analytical Control Systems	JPA	Class II	1993-03-23
K925190	Pyloriscreen	New Horizons Diagnostics Co.	LYR	Class I	1993-03-23
K924882	Toxoplasma Igm Ifa Test System	Zeus Scientific LLC	GLZ	Class II	1993-03-23
K924835	Valu-Pak Sterile Suture Removal Kit (Ahc-50-549560	American Healthcare Supply Co., Inc.	MCZ	Class I	1993-03-23
K924834	Premiere Sterile Suture Removal Kit(hc-50-54957)	American Healthcare Supply Co., Inc.	MCZ	Class I	1993-03-23
K924723	Cadwell Sierra	Cadwell Laboratories, Inc.	GWF	Class II	1993-03-23
K924577	Medivac	Medisonic U.S.A., Inc.	GCX	Class II	1993-03-23
K924117	Dexide Laparoscopic Kits	Dexide, Inc.	KDD	Class I	1993-03-23
K923600	Endo Optiks Value Pack	Endo Optics, Inc.	LRO	Class II	1993-03-23
K923555	Codman Gaab Neuroendoscope	Cerenovus, Inc.	GWB	Class I	1993-03-23
K922962	Various Cameo Med Basic Biopsy Trays, Disposable	Cameo, Inc.	KKX	Class II	1993-03-23
K922961	Various Cameo Med Percutaneous Skin Prep Trays,	Cameo, Inc.	KKX	Class II	1993-03-23
K922533	IV Start Kit Custom Smp # a-Z	Specialty Medical Products Co.	LRS	Class II	1993-03-23
K922128	Hospital Kit Ep 104	Savoy Medical Supply Co., Inc.	MDM	Class I	1993-03-23
K921497	Propaq Monitors, Modification	Protocol Systems, Inc.	CCK	Class II	1993-03-23
K920979	Codman Steerable Endoscope (Cat.# 83-1340)	Cerenovus, Inc.	GCQ	Class II	1993-03-23
K920915	Capnomed 100 Stand-Alone Etco2 Module	Mennen Medical, Inc.	CCK	Class II	1993-03-23
K920628	Quinevac Evacuator/aspirator	Recto Molded Products, Inc.	BTA	Class II	1993-03-23
K920267	Dyonics Arthroscopic Kit	Smith & Nephew Dyonics, Inc.	LRO	Class II	1993-03-23
K915837	Non-Balloon Replacement Gastrostomy System	C.R. Bard Inc	KNT	Class II	1993-03-23