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 2026-10-12, 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 3313 of 3528

510(k) clearances, page 3313 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K810093	Emit-St Phencyclidine Assay	Syva Co.	LCM	Unclassified	1981-02-02
K810092	Cholesterol Standard	Anco Medical Reagents & Assoc.	JIS	Class II	1981-02-02
K810078	Q-Pak Therapeutic Drug Monit. Control S	Hyland Therapeutic Div., Travenol Laboratories	DIF	Class I	1981-02-02
K810069	Sterile Airway	Medspec Corp.	CAE	Class I	1981-02-02
K810055	Stanbio Bilirubin Test Set	Stanbio Laboratory	CIG	Class II	1981-02-02
K810051	Selectron Remote Isotope	Victoreen, Inc.	JAQ	Class II	1981-02-02
K810006	Tomomatic 64	Medimatic S.r.l.	IZD	Class I	1981-02-02
K803294	Guardian Sterilization Wrap	Kimberly-Clark Corporation	FRG	Class II	1981-02-02
K803260	Sensomat Muscle/tissue Ph	Biochem International, Inc.	CBZ	Class II	1981-02-02
K803244	Assay Strips	Corning Costar Corp.	JTC	Class I	1981-02-02
K803232	Compressed Air & Oxygen Gen./delivery Sy	Dri-Aire, Inc.	CAW	Class II	1981-02-02
K803157	Auto-Mate Camera	Aptek, Ltd.	IYO	Class II	1981-02-02
K803000	Ionescu-Shiley Aortic Graft Valve	Shiley, Inc.	DSY	Class II	1981-02-02
K802990	Alginate/silicone Crown & Bridge Mater	Buffalo Dental Mfg Co Inc	ELW	Class II	1981-02-02
K802978	Transcutaneous Blood Oxygen Monitor #300	Brattle Instrument Corp.	KLK	Class II	1981-02-02
K802919	ISO-Bac Instrument Wrap	American Convertors Div., American Pharmaseal	FRG	Class II	1981-02-02
K810079	Sarns Integrated Cardioplegia Deliv. Sys	3M Health Care, Sarns	KRI	Class I	1981-01-30
K810104	ECG Arrhythmia Stimulator	Belmont Medical Technologies	DPS	Class II	1981-01-29
K810103	Adult ECG Electrode #60-0724	Aspen Laboratories, Inc.	DRX	Class II	1981-01-29
K810102	Infant ECG Electrode #60-1029	Aspen Laboratories, Inc.	DRX	Class II	1981-01-29
K810101	Water Resistant Footswitch W/cable	Aspen Laboratories, Inc.	GEI	Class II	1981-01-29
K810036	Siemens-Elema Myocardial Lead	Siemens Elema AB	DXY	Class III	1981-01-29
K803300	Inpersol Capd Bag Port Clamp	Abbott Medical	KDJ	Class II	1981-01-29
K803292	Field Suction Dissector	V. Mueller O.V. Baxter Healthcare Corp.	GDI	Class I	1981-01-29
K803175	Rubella Virus Serological Reagents	Microbiological Research Corp.	LFX	Class II	1981-01-29
K803134	Toxoplasma Gondii Serological Reagents	Microbiological Research Corp.	GLZ	Class II	1981-01-29
K803133	Rubella Virus Serological Reagent Rubel	Microbiological Research Corp.	LFX	Class II	1981-01-29
K802364	Extracorporeal's Exp 400 Parallel Plate	Extracorporeal Medical Specialities, Inc.	FJG	Class II	1981-01-29
K802299	K/k (Asma/ana) Universal Biopak	Bioware Products	DHN	Class II	1981-01-29
K810160	Tampax Maxithins Pads	Tampax, Inc.	HHD	Class I	1981-01-28
K810132	Model 2 Flowmeter	Harris Calorific	CAN	Class I	1981-01-28
K810088	Uric Acid (Tptz) Colorinmetric	Bio-Analytics Laboratories, Inc.	CDH	Class I	1981-01-28
K810086	Iron & Ticb	Bio-Analytics Laboratories, Inc.	JQF	Class I	1981-01-28
K810085	Iron Kit	Bio-Analytics Laboratories, Inc.	CFM	Class I	1981-01-28
K810083	Ldh-L Liquid Enzymatic, Kinetic Kit	Bio-Analytics Laboratories, Inc.	CFJ	Class II	1981-01-28
K810077	Omega Therapeutic Drug Monit. Control S.	Hyland Therapeutic Div., Travenol Laboratories	DIF	Class I	1981-01-28
K810065	Scott Cm42 Pasteurizer	William Harvey Life Products Corp.	HGX	Class II	1981-01-28
K810054	Rica (Diagnostic Instruments)	Robert I. Chien & Assoc., Inc.	GWZ	Class I	1981-01-28
K810053	Johnson & Johnson Adhesive Film Dressing	Johnson & Johnson Professionals, Inc.	KGX	Class I	1981-01-28
K810042	Bactec Bacterial Detection System: #5	BD Becton Dickinson Vacutainer Systems Preanalytic	JTA	Class I	1981-01-28
K810039	Mic-2000 Inoculum Tray Lid	Dynatech Corp.	JTC	Class I	1981-01-28
K810026	Dental Endodontic Cement	Witech Laboratory	EMA	Class II	1981-01-28
K810011	Gamma Stick 125-1 Tobramycin Ria Kit	Alpha Gamma Laboratory	KLB	Class II	1981-01-28
K810010	Orthodontic Elastics	Orec Corp.	ECI	Class I	1981-01-28
K803293	Guardian Peel Pouches	Kimberly-Clark Corporation	FRG	Class II	1981-01-28
K803291	Artus Drill #2000	JEDMED Instrument Company	DZI	Class II	1981-01-28
K803290	Artus Drill #3000	JEDMED Instrument Company	DZI	Class II	1981-01-28
K803289	Artus Drill #4000	JEDMED Instrument Company	DZI	Class II	1981-01-28
K803288	Artus Drill #6000	JEDMED Instrument Company	DZI	Class II	1981-01-28
K803255	Automated Pulmonary Function Laboratory	Cardio Pulmonary Instruments	BZC	Class II	1981-01-28