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 3153 of 3528

510(k) clearances, page 3153 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831558	E-Z Prep	Coulter Electronics, Inc.	GKJ	Class I	1983-06-16
K831553	Leg Drainage Bag Strap Bk6011	Fred Sammons, Inc.	KNX	Class II	1983-06-16
K831464	Aso-Check	Diagnostic Technology, Inc.	GTQ	Class I	1983-06-16
K831419	Raichem Ldh-P Reagent W/separate Start-	Reagents Applications, Inc.	CFJ	Class II	1983-06-16
K831417	Emit Qst Tobramycin Control	Syva Co.	LAS	Class I	1983-06-16
K831415	Lactic Dehydrogenase Reagent Set	Sterling Biochemical, Inc.	CFJ	Class II	1983-06-16
K831414	Colorimetric Bun	Bio-Analytics Laboratories, Inc.	CDL	Class II	1983-06-16
K831393	Vasculab Blood Pressure Cuff	Medasonics, Inc.	DXQ	Class II	1983-06-16
K831306	Hemacal	Hematology Marketing Assoc.	KRZ	Class II	1983-06-16
K831289	Prefilled Iec Columns	Berwick Medical Products, Inc.	DJY	Class I	1983-06-16
K831098	Dominion	Unitek Corp.	EJT	Class II	1983-06-16
K831069	Dac-Cel Pth Kit Rd51	Wellcome Diagnostics	CEW	Class II	1983-06-16
K831067	Breathing Zone	Upper Four, Inc.	FRF	Class II	1983-06-16
K831025	Electrolyle Carbon Dioxide Electrodes	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-16
K831024	Electrolyte Po2 for Oxygen Electrodes	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-16
K831021	Calibrating Solution for Abl-1 & 2	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-16
K831019	Ph 6.838 Ref. Buffer	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-16
K831018	Calibrating Solution for Abl-1 & 2	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-16
K830968	Rapid Identifi-Method Neisseria Kit	Austin Biological Laboratories	JTO	Class I	1983-06-16
K830935	Hemoglobin Alc by Column Test	Bio-Rad	LCP	Class II	1983-06-16
K830831	Automated Blood Cell Separator	Cryosan, Inc.	LKN	Unclassified	1983-06-16
K830793	Patient Guided Elbow & Shoulder Exerc	Richard'S Medical Equip., Inc.	BXB	Class I	1983-06-16
K830753	Needle Guide Model 21285A	Hewlett-Packard Co.	LFL	Unclassified	1983-06-16
K830720	Graf Meniscal Suture Set	Acufex Microsurgical, Inc.	FZX	Class I	1983-06-16
K830719	Universal Cannula	Acufex Microsurgical, Inc.	GCJ	Class II	1983-06-16
K831615	Drop Foot Brace	Edward Dilauro, Jr.	IQI	Class I	1983-06-15
K831595	Castle Model 3341 & 3441 & 4141 Gas Aer	Castle Co.	FLI	Class II	1983-06-15
K831590	T-Tube Inserter	Treace Medical, Inc.	EQH	Class I	1983-06-15
K831588	Instrument Guard Capsule	Treace Medical, Inc.	KCT	Class II	1983-06-15
K831582	Vari-Support Neck Posture Pillow	Body Therapeutics, Inc.	IQK	Class I	1983-06-15
K831479	Metal-Backed Acetabular Cup	Dow Corning Corp. Healthcare Industries Materials	DXQ	Class II	1983-06-15
K831358	Autoantibody Screen Test System	Zeus Scientific LLC	DBM	Class II	1983-06-15
K831329	Pmt Vaxiom Stereotactic Sys #Fx001	Progress Mankind Technology	HAW	Class II	1983-06-15
K831309	Delivery 4 Table	Amsco Co.	KNC	Class II	1983-06-15
K831161	Command Ultra I	Cardiac Pacemakers, Inc.	DXY	Class III	1983-06-15
K831097	Concerto	Unitek Corp.	EJS	Class II	1983-06-15
K831096	Stroma II	Unitek Corp.	EJS	Class II	1983-06-15
K831023	Reference Buffer Ph 7.382	Fisher Scientific Company L.L.C.	CHL	Class II	1983-06-15
K830906	Pulsamat Model 1050	Ferring Laboratories, Inc.	FRN	Class II	1983-06-15
K830892	Thermodilution Cardiac Output Computer-	American Edwards Laboratories	DXG	Class II	1983-06-15
K830864	White Blood Cell Control	Control Diagnostics	JPK	Class II	1983-06-15
K830655	Quik-Silver Resting ECG Electrode	Quinton, Inc.	DRX	Class II	1983-06-15
K830517	Central Station Display/recorder Matrix	Marquette Electronics, Inc.	DRT	Class II	1983-06-15
K823552	Appose Skin Stapler & Remover	American Cyanamid Co.	GDW	Class II	1983-06-15
K837517	Infradiode Infrared Lamp	Phimo of Texas, Inc.			1983-06-14
K837494	Baby Light Meter	Rocky Mountain Medical Corp.			1983-06-14
K837513	Unknown	Xerox Corp.			1983-06-13
K837491	Rex Pedestal Intra-Oral X-Ray Unit	The Yoshida Dental Mfg. Co., Ltd.			1983-06-13
K830824	Urine Screening Kit	Syn-Kit, Inc.	CEN	Class I	1983-06-12
K821178	Ethicon External Fixation Wire	Ethicon, Inc	FYI	Class I	1983-06-11