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 2384 of 3531

510(k) clearances, page 2384 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920310	Sienet Archive Server, Isa I, Isa II Storage Serve	Siemens Gammasonics, Inc.	LMD	Class I	1992-03-30
K920289	Cordis Bipal 7 Biopsy Forceps	Cordis US Corp.	DWZ	Class II	1992-03-30
K920115	Mediscint	Oakfield Instruments, Ltd.	IZD	Class I	1992-03-30
K920061	Hemometrix Continuous Blood Gas Monitoring System	Abbott Medical	CBZ	Class II	1992-03-30
K920041	Adac Xl-Plan-Pc	Philips North America LLC	IYE	Class II	1992-03-30
K915863	Mega Amniocentesis Kit	Mega Medical, Inc.	HIO	Class I	1992-03-30
K915429	Kronus Kalibre Thyroid Peroxidase Antibody Eia Kit	Kronus, Inc.	JZO	Class II	1992-03-30
K915428	Kronus Kalibre Thyroglobulin Antibody Eia Kit	Kronus, Inc.	JZO	Class II	1992-03-30
K915340	Mentor Horizon Low Vision Magnifier	Mentor O & O, Inc.	HJG	Class I	1992-03-30
K915233	Myoglobin Ria Test Kit	Pro Diagnostics, Inc.	DDR	Class II	1992-03-30
K914755	Davol Laparoscopic Cholangiogram Catheter & Kit	Davol, Inc.	GCA	Class II	1992-03-30
K914383	Life-Air 1000 Patient Warming Covers	Progressive Dynamics, Inc.	DWJ	Class II	1992-03-30
K914206	Ars-EKG 12K Interpretive Electrocardiography Syst	Kardiosis Ltd. Co.	DPS	Class II	1992-03-30
K913361	Drain/priming/recirculation Bag	Haemotronic, Inc.	KOC	Class II	1992-03-30
K921057	Amylase Reagent	Genzyme Corporation	JFJ	Class II	1992-03-27
K920782	Olympic Trans-Lite	Olympic Medical Corp.	KYT	Class I	1992-03-27
K920712	Medix Biotech Throxine Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	KLI	Class II	1992-03-27
K920562	Unistik	Ulster Scientific, Inc.	FMK	Class II	1992-03-27
K920265	Bair Hugger Patient Warming System	Augustine Medical, Inc.	DWJ	Class II	1992-03-27
K915816	Bite Block/mouthpiece for Endoscopy	Gi Supply	EOQ	Class II	1992-03-27
K915814	Sex Crimes/sex Assault Vict/suspect Evid Coll Kits	Sirchie Finger Print Laboratories, Inc.	JKA	Class II	1992-03-27
K915627	Paceview	Micromedical Industries, Ltd.	KRB	Class II	1992-03-27
K915624	Modified Biolog	Micromedical Industries, Ltd.	DRT	Class II	1992-03-27
K915583	CO2 Laser and Waveguide Delivery Systems for Thor.	Heraeus Lasersonics, Inc.	GEX	Class II	1992-03-27
K915215	Continuous Arteriovenous Hemofiltration Cath. Kits	Akcess Medical Products, Inc.	LFK	Class II	1992-03-27
K915105	Foxell Plus Multiple(personal Touch), Modification	Wah-Chang and Stone Lion	LYY	Class I	1992-03-27
K914827	Lpi Ml210 Holmium Surgical Laser, Modification	Laser Photonics, Inc.	GEX	Class II	1992-03-27
K913891	Disetronic(r) Infusor	Disetronic Medical Systems	FRN	Class II	1992-03-27
K913848	Sharplan Model Ultra Ultrasonic Surg Aspirator	Sharplan Lasers, Inc.	MGI	Class III	1992-03-27
K913595	Ds-240 Ambulatory Blood Pressure Monitoring System	Koven and Assoc., Inc.	DXN	Class II	1992-03-27
K912662	Scale-Tronix Platform Scale	Scale-Tronix, Inc.	FRW	Class I	1992-03-27
K910777	Mdt/castle Models S-8 Table Top Steam Sterilizer	Mdt Biologic Co.	FLE	Class II	1992-03-27
K905425	Sporview	Spsmedical Supply Corp.	FRC	Class II	1992-03-27
K921071	Dentolock	Dentmed, Ltd.	KOB	Class II	1992-03-26
K920917	Elisa Tube Fsh Test Kit Enzyme Linked Immun. Assay	Bio Clinic Co.	CGJ	Class I	1992-03-26
K920856	Ventrex Coated Tube High Sensit. Tsh Radioimmunoas	Hycor Biomedical	JLW	Class II	1992-03-26
K920553	Myriadlase Sidefire-Tipped Optical Fiber	Myriad Lase, Inc.	GEX	Class II	1992-03-26
K920534	Porcelain Primer	Confi-Dental Products Co.	DYH	Class II	1992-03-26
K920368	Ulcuflex Hydrocolloid Paste	Industrias Palex C/O Dma Med-Chem Corp.	KMF	Class I	1992-03-26
K920367	Ulcuflex Hydroculloid Dressing	Industrias Palex C/O Dma Med-Chem Corp.	KMF	Class I	1992-03-26
K920366	Ulcuflex Hydrocoloid Powder	Industrias Palex C/O Dma Med-Chem Corp.	KMF	Class I	1992-03-26
K920244	Dw240 #73C Alloy for Porcelain Fused to Metal	Ivoclar North America, Inc.	EJT	Class II	1992-03-26
K920182	Marion Window	Tnt Moberg Intl., Ltd.	KGX	Class I	1992-03-26
K920133	Versacath Selectalumen Inner Catheter	Menlo Care, Inc.	FOZ	Class II	1992-03-26
K920128	Versacath Mainline Central Venous Catheter	Menlo Care, Inc.	FOZ	Class II	1992-03-26
K920028	Landmark Midline Catheter	Menlo Care, Inc.	FOZ	Class II	1992-03-26
K915822	Multiple Dressing, Sterile Nonaddherent Pads	Kerma Medical Products, Inc.	NAB	Class I	1992-03-26
K915650	Human Igg Subclass Rid Kit	Janssen Biochimica	CGM	Class II	1992-03-26
K915536	Davol 100Cc Silicone Closed Wound Drainage Evac	Davol, Inc.	GCY	Class I	1992-03-26
K914969	E350i Electrocardiograph	Siemens Burdick, Inc.	LOS		1992-03-26