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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2963 of 3529

510(k) clearances, page 2963 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851943	Coulter Volume Adapter	Coulter Electronics, Inc.	GKL	Class II	1985-08-30
K850368	Sigms B-Hydroxybutarate Procedure No. 310-UV	Sigma Chemical Co.	JIN	Class I	1985-08-30
K853534	Bbl Campy Pouch	BD Becton Dickinson Vacutainer Systems Preanalytic	KZJ	Class I	1985-08-29
K853462	Coagulation Factor VIII Deficient Substrate Plasma	American Dade	GGP	Class II	1985-08-29
K853461	Coagulation Factor IX Deficient Substrate Plasma	American Dade	GGP	Class II	1985-08-29
K853350	Synchroner Tm (Proposed Tradename)	Fisons Corp.	CCQ	Class I	1985-08-29
K853344	4000 Non Conductive Anesthesia Ventilator Circuit	Sigma Medical, Inc.	CAI	Class I	1985-08-29
K853343	3015 Pediatric Non-Conductive Anesthesia Circuit W	Sigma Medical, Inc.	CAI	Class I	1985-08-29
K853342	6013 Non Conductive Anesthesia Circuit W/breathbag	Sigma Medical, Inc.	CAI	Class I	1985-08-29
K853336	Dnase W/toluidine Blue, Dnase W/indicator	Hardy Media	JSH	Class I	1985-08-29
K853263	Precept Avgmentin	Austin Biological Laboratories	LTW	Class II	1985-08-29
K853192	Kotex Security Tube Tampon	Kimberly-Clark Corporation	HEB	Class II	1985-08-29
K853071	Medix Electronic Nebulizing System	Medix Corp.	CCQ	Class I	1985-08-29
K853053	Precept Erythromycin	Austin Biological Laboratories	LTW	Class II	1985-08-29
K853004	Portable Oxygen Unit	B & F Medical Products, Inc.	CAW	Class II	1985-08-29
K852985	Unscented Always Pantiliners	Procter & Gamble Mfg. Co.	HHD	Class I	1985-08-29
K852894	Ormco Transmandibular Implant	Ormco Corp.	MDL	Class II	1985-08-29
K852880	Peel-Away Sheath(a Component of Argon Introd Set)	Argon Medical Corp.	DYB	Class II	1985-08-29
K852867	Hi-Chem Diagnostics Enzyme Rinse Concentrate	Hi Chem, Inc.	CKA	Class I	1985-08-29
K852663	Portable Gaseous Oxgyen Container	Cryogenic Assoc.	CAN	Class I	1985-08-29
K851845	Numed Temp. Stylet Pacing Parobe 1318694	Numed Inc	LDF	Class II	1985-08-29
K851745	1-100 Universal Set Otoscope & Larynx Exploraton B	Artiberia	ERA	Class I	1985-08-29
K851731	Ela Medical Pacing Leads Pmc 860 Pmcf 860 Pbcf860	Ela Medical, Inc.	DTB	Class III	1985-08-29
K851485	Defi 502	Robert Bosch Corp.	LDD	Class II	1985-08-29
K850968	Medtronic Model 4016 Bipolar Endocardial Screw-in	Medtronic, Inc.	DTD	Class II	1985-08-29
K844948	Syva Solid Phase Columns	Syva Co.	KEA	Class I	1985-08-29
K844814	Biopore 493-05 Endocardial Implantable Pacing Lead	Intermedics, Inc.	DTD	Class II	1985-08-29
K853500	Ortho Viral Transport	Ortho Diagnostic Systems, Inc.	JSM	Class I	1985-08-28
K853497	Prefilled Specimen Jars 10% Neutral Buf-Formalin	Surgipath Medical Industries, Inc.	IFP	Class I	1985-08-28
K853488	Staph Kit	Culture Kits, Inc.	JSI	Class I	1985-08-28
K853463	Lx Embedding Center	Innovative Medical Systems, Inc.			1985-08-28
K853448	Hillcrest Amebiasis Iha Test	Hillcrest Biologicals	KHW	Class II	1985-08-28
K853361	H-H Ventricular Catheters & Reservoirs	Holter-Hausner Intl.	JXG	Class II	1985-08-28
K853048	Apo-Screen Test Set for Hdl-Apolipoptein a-1	Photec Diagnostics, Inc.	DER	Class II	1985-08-28
K852878	The Dpc Monoclonal Eia Total Ige Kit	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1985-08-28
K852838	Advanced Medical Products Mes TENS	Advanced Medical Products, Inc.	GZJ	Class II	1985-08-28
K852837	Advanced Medical Products Dr Pulse (TENS)	Advanced Medical Products, Inc.	GZJ	Class II	1985-08-28
K852836	Advanced Medical Products Mini-M (TENS)	Advanced Medical Products, Inc.	GZJ	Class II	1985-08-28
K853458	H-H Sexton Scup Urine Mgmt. Sys	Holter-Hausner Intl.	KNX	Class II	1985-08-27
K853309	P.a. Enteral Feeding Bag 1100	Pa Medical Corp.	KNT	Class II	1985-08-27
K852966	Enteral Feeding Container	Empire Industries, Inc.	KNT	Class II	1985-08-27
K852951	Welch Allyn Fiber Optic Cables Various Models	Welch Allyn Inc	FCW	Class II	1985-08-27
K852924	Laurier Safety Long Sanitory Napkin	Kao Corp.	HHD	Class I	1985-08-27
K852619	Uri-Sure	Ashai Co., Ltd.	KNX	Class II	1985-08-27
K851410	O.m.s. UV-Colours	Optical Moulding Systems	HQG	Class I	1985-08-27
K853441	Fetal Bovine Serum in Transfer Container	Newport Biosystems, Inc.	KJA	Class I	1985-08-26
K853265	Accupac Custom Operating Room Procedure-Dk876543	Geneva Laboratories, Inc.			1985-08-26
K853139	Phoenix Anesthesia Machine	American Anesthesia, Inc.	BSZ	Class II	1985-08-26
K852922	Laurier Overnight Sanitary Napkin	Kao Corp.	HHD	Class I	1985-08-26
K852815	Triple Lumen Right Atrial Catheter	Quinton, Inc.	DQY	Class II	1985-08-26