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 3400 of 3526

510(k) clearances, page 3400 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791156	Amipaque Myelogram Tray	Pharmaseal Div., Baxter Healthcare Corp.	FMI	Class II	1979-07-30
K791151	ECG Channel of Diagnostic System	Honeywell, Inc.	DPS	Class II	1979-07-30
K791146	Colo-Tape	Suburban Ostomy Supply Co., Inc.	EZR	Class I	1979-07-30
K791127	Posivac	Vital Signs, Inc.	CBN	Class II	1979-07-30
K791119	Macomb Normal Control Serum	Macomb Chemical Co.	JJY	Class I	1979-07-30
K791111	Automated Electrophoreses Machine	Gelman Sciences, Inc.	JJN	Class I	1979-07-30
K791065	Immunospot Tsh Test	Meloy Laboratories, Inc.	JLW	Class II	1979-07-30
K791056	3M Cement Remover	3M Company	HSZ	Class I	1979-07-30
K790975	Somatom 2	Siemens Corp.	JAK	Class II	1979-07-30
K790922	Disposable Adult Diaper	Fibre Formations, Inc.	EYQ	Class I	1979-07-30
K790898	Preg-Tex	Biologics Intl., Inc.	JHJ	Class II	1979-07-30
K790875	Monoject Endometrial Sampling Kit	Sherwood Medical Co.	HHK	Class II	1979-07-30
K790853	Easy-Spec	C. Intl.	KNA	Class II	1979-07-30
K790852	Vagi-Spec	C. Intl.	KNA	Class II	1979-07-30
K790851	Vagi-Press #401	C. Intl.	KOH	Class I	1979-07-30
K790836	Guardian II i.v. Controller	Centaur Sciences, Inc.	FLN	Class II	1979-07-30
K790811	Exeter Bone Lauage System	Howmedica Corp.	FQH	Class II	1979-07-30
K790759	Iif-Apca Test Kit	Medica Corp.	DBJ	Class II	1979-07-30
K790693	Hyperbaric Oxygen Chamber	Hyperbaric Oxygen Therapy, Inc.	CBF	Class II	1979-07-30
K790631	Steraid Surgical Dressing	Corda Intl. Holdings, Inc.	EFQ	Unclassified	1979-07-30
K790602	Ria, Dignxin-125-I	Endocrine-Metabolic Center	DPB	Class II	1979-07-30
K790576	Quantimune T-4 Fia	Bio-Rad	CDX	Class II	1979-07-30
K790446	Ovalith-300	Coratomic, Inc.	DXY	Class III	1979-07-30
K791289	Gizmo Towel Clamp	Hemoy, Inc.	HXD	Class I	1979-07-24
K791286	Weck Microsurgical Knife	Vista Medical Products, Inc.	EMF	Class I	1979-07-24
K791280	Operation Microscope Som 1	Elmed, Inc.	FSO	Class I	1979-07-24
K791276	Pervenous Lead Introducer System	Cordis US Corp.	DQX	Class II	1979-07-24
K791273	Conphar Oxygen Catheter-Sterile	Conphar, Inc.	BZB	Class I	1979-07-24
K791267	Secutex Ankle Band	Conphar, Inc.	IQI	Class I	1979-07-24
K791266	Secutex Knee Band	Conphar, Inc.	IQI	Class I	1979-07-24
K791249	Secutex Wrist Brace	Conphar, Inc.	IQI	Class I	1979-07-24
K791248	Secute Elbow Band	Conphar, Inc.	IQI	Class I	1979-07-24
K791247	Conphar Nasal Oxygen Cannula-Sterile	Conphar, Inc.	CAT	Class I	1979-07-24
K791241	Briox Model 2000-Ca Compressor Unit	Briox Technologies, Inc.	JCX	Class II	1979-07-24
K791240	Briox Model 2000-C Compressor Unit	Briox Technologies, Inc.	JCX	Class II	1979-07-24
K791239	Briox Model 2000-a Aspirator Unit	Briox Technologies, Inc.	JCX	Class II	1979-07-24
K791238	Briox Model 2000-Cq Quiet Compressor	Briox Technologies, Inc.	JCX	Class II	1979-07-24
K791210	Portable Aspirator	Sam Say Assoc.	JCX	Class II	1979-07-24
K791138	5880 Series of Gas Chromatographs	Hewlett-Packard Co.	KZQ	Class I	1979-07-24
K791137	Single Use Monopolar Hand Control Pencil	Davol, Inc.	GEI	Class II	1979-07-24
K791105	B & L Ophthalmic Chair	Bausch & Lomb Incorporated	HMF	Class I	1979-07-24
K791104	B & L Ophthalmic Instrument Stand	Bausch & Lomb Incorporated	HMF	Class I	1979-07-24
K791094	3M Orthopedic Casting Tape	3M Company	ITG	Class I	1979-07-24
K791080	Plus Chem S.c.e. Reagent	Smithkline Diagnostics, Inc.	CIT	Class II	1979-07-24
K791077	Beckman Electrophoresis Oven/incubator	Beckman Instruments, Inc.	JRJ	Class I	1979-07-24
K791051	Progesterone Radioimmunoassay Kit	Cis Radiopharmaceuticals, Inc.	JLS	Class I	1979-07-24
K791022	Prothrombin Reference Plasma (Human)	Pacific Hemostasis	GJS	Class II	1979-07-24
K790997	Anti-Dnase B Reagent System	Calbiochem-Behring Corp.	GTR	Class I	1979-07-24
K790892	Misty Nebulizer	Airlife, Inc.	CAF	Class II	1979-07-24
K790883	Stress/emergency Eelctrode	Hayes Products, Inc.			1979-07-24