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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3060 of 3528

510(k) clearances, page 3060 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841723	Adler Custom Procedure Packs	Adler Instrument Company			1984-08-01
K842377	Ms Nonprecious Crown & Bridge Alloy	Dental Ventures of America, Inc.	EJH	Class II	1984-07-31
K842358	Isolight	Planmeca U.S.A. Inc	EBA	Class I	1984-07-31
K842274	F-G-P Tray	Di-Equi Dental Products	EHY	Class I	1984-07-31
K842273	Crown Index Tray	Di-Equi Dental Products	EHY	Class I	1984-07-31
K842208	Natura-Tone or Luxopal Cl Acrylic	Parexel Intl. Corp.	ELM	Class II	1984-07-31
K842185	Protex Contracept Plus W/sperm-Lub	National Sanitary Laboratories, Inc.	HIS	Class II	1984-07-31
K842154	Packets for the Prep of Dialysates &	bioMerieux, Inc.	FKQ	Class II	1984-07-31
K841909	Vaginal Speculum - Disposable	Galenica Enterprises, Inc.	HIB	Class II	1984-07-31
K841310	Gastrointestinal Dilator	Thomas J. Fogarty, M.D.	KNQ	Class II	1984-07-31
K834455	Monoxychlorosene Warexin	Guardian Chemical	FKQ	Class II	1984-07-31
K832290	Cystoflo Antimicrobial Urinary Drainage	Travenol Laboratories, S.A.	KNX	Class II	1984-07-31
K843001	Cook Pacemaker Corp. 116 Biopolar Cardi	Cook Pacemaker Corp.			1984-07-30
K841271	Infra-Eye 160	Fujitsu, Ltd.	LHQ	Class I	1984-07-28
K842843	Dryden Scavenger Interface System	Dryden Corp.			1984-07-27
K842774	Codman Suction Punch-Product Codes	Cerenovus, Inc.	HTZ	Class I	1984-07-27
K842696	Life-Mask Infant Resuscitator	Electronic Monitors, Inc.	BTM	Class II	1984-07-27
K842636	Technicon H*1 System	Technicon Instruments Corp.	GKZ	Class II	1984-07-27
K842605	Respironics Vent Easy Oxygen Enrichme	Respironics, Inc.	CAE	Class I	1984-07-27
K842584	Hek	Viromed Laboratories, Inc.	KIR	Class I	1984-07-27
K842583	Sirc	Viromed Laboratories, Inc.	KIR	Class I	1984-07-27
K842579	B.e.c. Growth Chek Microbial Suspensions	Biological & Environmental Control Laboratories	JTR	Class I	1984-07-27
K842440	Sickle Cell Stat a/s Heterozygous-Eryth	Anco Medical Reagents & Assoc.	JPK	Class II	1984-07-27
K842414	Echo Pulse Burst	Rabar, Inc.	GZJ	Class II	1984-07-27
K842346	Coulter Automatic Sample Handler	Coulter Electronics, Inc.	GKL	Class II	1984-07-27
K842146	Histopaque-1077	Sigma Chemical Co.	JCF	Class I	1984-07-27
K842109	Technicon Test Point Assayed Hematology	Technicon Instruments Corp.	JPK	Class II	1984-07-27
K842077	Midas II Automatic Stainer	Innovative Medical Systems, Inc.	KPA	Class I	1984-07-27
K841991	Arm-a-Care Humidifier-Respiratory Gas	Armour Pharmaceutical Co.	CCQ	Class I	1984-07-27
K841990	Arm-a-Care Nebulizer-Nebulizer	Armour Pharmaceutical Co.	CCQ	Class I	1984-07-27
K841989	Arm-a-Vial Lv Sodium Chloride Inhalat	Armour Pharmaceutical Co.	CCQ	Class I	1984-07-27
K841988	Arm-a-Vial Lv Sodium, Chloride Inhalat	Armour Pharmaceutical Co.	CCQ	Class I	1984-07-27
K841987	Arm-a-Vial Lv Sterial Water for Inhala	Armour Pharmaceutical Co.	CCQ	Class I	1984-07-27
K841827	Enteroport Nutrition Pump	Diatek, Inc.	FRN	Class II	1984-07-27
K841822	Keymed Sigmoidoscope Suction Unit	Keymed, Inc.	DRM	Class II	1984-07-27
K841531	Para-Tek	Streck Laboratories, Inc.	JPK	Class II	1984-07-27
K841443	Redo Central Venous Catheter-Neonate	Intl. Hospital Products, Inc.	LJS	Class II	1984-07-27
K841248	Sunglasses	China Toy & Novelty Co., Ltd.	HQG	Class I	1984-07-27
K841172	Monitor One	Qmed, Inc.	DSI	Class II	1984-07-27
K842778	Avatron Universal Adult Vol. Ventilator	Avatron, Inc.	BZO	Class I	1984-07-26
K842760	Lung Analyzer Cm-310	Cybermedic, Inc.	BZC	Class II	1984-07-26
K842688	Bear Jet-150 Ventilator	Bear Medical Systems, Inc.	CBK	Class II	1984-07-26
K842631	Sterelis Sealing Equipment	Sterelis Corp.	FLE	Class II	1984-07-26
K842619	Regular Petal Soft Plastic Applicator	Tambrands Inc.	HEB	Class II	1984-07-26
K842618	Super Petal Soft Plastic Applicator Tamp	Tambrands Inc.	HEB	Class II	1984-07-26
K842598	Star Hcg Monoclonal Antibody Immuno	Syncor Intl. Corp.	JHI	Class II	1984-07-26
K842541	Rapid Plasma Reagin Card Test	Clinical Sciences, Inc.	GMQ	Class II	1984-07-26
K842416	Duo Flow Catheter-Mc 54	Medical Components, Inc.	KNZ	Class II	1984-07-26
K842392	Delton * Opaque Light Curing Pit	Johnson & Johnson Professionals, Inc.	EBC	Class II	1984-07-26
K842292	Cefonicid 30 Mcg Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1984-07-26