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 2026-11-02, 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 2437 of 3531

510(k) clearances, page 2437 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913125	Roche Reagent for Ethanol	Roche Diagnostic Systems, Inc.	DIC	Class II	1991-08-12
K913124	Roche Reagent for Ammonia	Roche Diagnostic Systems, Inc.	JIF	Class I	1991-08-12
K913107	Abuscreen(r) Ontrak(r) Positive Ref Cont Benzodiaz	Roche Diagnostic Systems, Inc.	LAS	Class I	1991-08-12
K913105	Reflotron Creatinine Test Tabs	Boehringer Mannheim Corp.	JFY	Class II	1991-08-12
K912862	Monoscopy(tm) Brank, Hook Dissector	Dexide, Inc.	GCJ	Class II	1991-08-12
K912850	Shbg	Wien Laboratories, Inc.	CDZ	Class I	1991-08-12
K912827	Serum Alcohol Control Levels 1, 2 & 3	Cala Diagnostics	DKC	Class I	1991-08-12
K912809	Abbott Quickstart Phosphorus(phos) Item #5A14	Em Diagnostic Systems, Inc.	CEO	Class I	1991-08-12
K912804	Fsh Irma Immunomag	Pantex, Div. Bio-Analysis, Inc.	CGJ	Class I	1991-08-12
K912795	Biotrol Uibc Reagent	Biotrol, USA, Inc.	JMO	Class I	1991-08-12
K912765	Stasis Button Prssure Device	Arch Development Group	MHW	Class I	1991-08-12
K912738	Avi Volumetric Infusion Pumps-Various Models	3M Avi, Inc.	FRN	Class II	1991-08-12
K912736	Erecaid(r) System Plus	Osbon Medical Systems, Ltd.	LKY	Class II	1991-08-12
K912583	Magic Lite Tsh (Hs) Immunoassay	Ciba Corning Diagnostics Corp.	JLW	Class II	1991-08-12
K912574	Abuscreen Online for Thc (50 and 100)	Roche Diagnostic Systems, Inc.	LAT	Class II	1991-08-12
K912541	Milenia Total T4, Catalog: Mkt41,5	Siemens Healthcare Diagnostics Inc.	CDX	Class II	1991-08-12
K912455	Dade Iac-X Comprehensive Immunoassay Control	Baxter Healthcare Corporation	JJY	Class I	1991-08-12
K912422	Surg/assist Model Sa-1	Surg-Assist, Inc.	FYD	Class II	1991-08-12
K912295	Kinamed Ath 28Mm Alumina Ceramic Long-Neck Ball	Kinamed Inc	LZO	Class II	1991-08-12
K912152	Cellabs Giardia Cel I.f. Test	Celltech Diagnostics, Ltd.	MHI	Class II	1991-08-12
K912148	Cholinesterase Test Kit	Crestat Diagnostics, Inc.	DIH	Class I	1991-08-12
K912109	Uresil General Purpose Drainage Catheter	Uresil, LLC	GBO	Class I	1991-08-12
K912089	Modified Series 2100 Endoscopes	Medical Laser, Inc.	ODF	Class II	1991-08-12
K912002	Playtex Non-Deodorant/deodorant Tampons	Playtex Family Products, Inc.	HIL	Class II	1991-08-12
K911903	Allergans Pharmacia Cap Sys.rast Ria/feia	Pharmacia, Inc.	DHB	Class II	1991-08-12
K911886	Pmt Metal Locator, Model 3630-1	PMT Corp.	HPM	Class II	1991-08-12
K911870	Scimed Optamum Operative Peripheral Angioplas Cath	Scimed Life Systems, Inc.	LIT	Class II	1991-08-12
K911834	Opus(r) Rozo	Pb Diagnostic Systems, Inc.	LGD	Class II	1991-08-12
K911790	Minimax (Tm) Collapsible Venous Reservoir Bag	Medtronic, Inc.	DTN	Class II	1991-08-12
K911658	Dialysis Trandsducer Protector	Tico Medical Instruments, Inc.	FIB	Class II	1991-08-12
K911195	Dunlap Heat Pad	Home Healthcare Products, Inc.	IRT	Class II	1991-08-12
K910821	Transducer Protector	Gelman Sciences, Inc.	FIB	Class II	1991-08-12
K910210	Slidex Meningite-Kit 5	Vitek Systems, Inc.	GTJ	Class II	1991-08-12
K905415	Braided High Pressure Catheter Connector	The R Group	FOZ	Class II	1991-08-12
K913350	Vital-Port(r) Petite Vascular Access System	Med Institute, Inc.	LJT	Class II	1991-08-09
K913270	Bivona Fome-Cuf(r) Pediatric Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1991-08-09
K912871	Inside Job	3M Company	HRX	Class II	1991-08-09
K912479	Motor Massage Pillow	Supreme Import, Ltd.	IRO	Class I	1991-08-09
K912428	Pb3300 Sensing Catheter for Continuous Measurement	Medtronic, Inc.	CBZ	Class II	1991-08-09
K912400	Mobile X-Ray Floor Stand	Dntl Corp.	IZL	Class II	1991-08-09
K912313	Solchrom-Pal	Metalor Dental USA Corp.	EJT	Class II	1991-08-09
K912308	Standard S32	Metalor Dental USA Corp.	EJS	Class II	1991-08-09
K912307	Standard S31	Metalor Dental USA Corp.	EJS	Class II	1991-08-09
K912305	Standard S3	Metalor Dental USA Corp.	EJS	Class II	1991-08-09
K912302	Vacu 2	Metalor Dental USA Corp.	EJS	Class II	1991-08-09
K912211	Intravascular Catheter Securment Device	Inman Liebelt Corp.	KMK	Class I	1991-08-09
K912170	Radioactive Iodine-125 Sources	Best Industries	IWI	Class II	1991-08-09
K912130	Tbd Keratoscope	Alcon Laboratories	HLQ	Class I	1991-08-09
K912117	Laceration Tray	Medical Device Inspection Company	MCY	Class II	1991-08-09
K912104	Major Basin Tray	Medical Device Inspection Company	FSM	Class I	1991-08-09