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 3202 of 3528

510(k) clearances, page 3202 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K828053	Adr Ultrasound 5.5 Mhz Short Focus Transducer	Adr Ultrasound			1982-09-29
K828051	Adr Ultrasound Model 4000 Sc or 4000 S/lc	Adr Ultrasound			1982-09-29
K828050	Adr Ultrasound Model 4000 L	Adr Ultrasound			1982-09-29
K828049	Adr Ultrasound Mc2 Large Cart	Adr Ultrasound			1982-09-29
K827928	Vrt Table	General Electric Co.	IZZ	Class II	1982-09-29
K827891	Ultrasonic Pulsed Echo Imaging System Rt30	General Electric Co.			1982-09-29
K827583	Stereotactic 60 Cobalt Gamma System--Gammaknife	Nucletronix, Inc.	IWB	Class II	1982-09-29
K827454	Unknown	Ote Biomedica			1982-09-29
K822760	Arterial Line Kit	Martell Medical Products, Inc.	FMF	Class II	1982-09-28
K822756	U.v.a.c. Curettes	American Hospital Supply	HHD	Class I	1982-09-28
K822740	K30000 Dental Chair	Kaycor Intl., Ltd.	KLC	Class I	1982-09-28
K822727	Rescuer	Armstrong Ind., Inc.	CAE	Class I	1982-09-28
K822719	Erie Oxygen Concentrator	Erie Controls			1982-09-28
K822714	Conclude Composite Luting Cement	3M Company	EBD	Class II	1982-09-28
K822657	Emit-Amd Amikacin Assay	Siemens Healthcare Diagnostics Inc.	KLQ	Class II	1982-09-28
K822653	Tdx Quinidine	Abbott Medical	LBZ	Class II	1982-09-28
K822640	Coronary Infusion Kit	Mallinckrodt Critical Care	DQO	Class II	1982-09-28
K822637	Nasal Septal Buttons	Abco Dealers, Inc.	LFB	Unclassified	1982-09-28
K822622	Root Canal Files, Type H (Hedstrom	Union Broach, Div. Moyco Industries, Inc.	EKS	Class I	1982-09-28
K822621	Root Canal Files, Type K	Union Broach, Div. Moyco Industries, Inc.	EKS	Class I	1982-09-28
K822620	Root Canal Reamers, Type K	Union Broach, Div. Moyco Industries, Inc.	EKP	Class I	1982-09-28
K822604	Acid Fast Quality Control Slides	Medastat Scientific Corp.	LJG	Class I	1982-09-28
K822598	Teflon Pigtail/percutaneous Cardiovas	Vertex Medical Corp.	DQO	Class II	1982-09-28
K822595	Vessel Dilator	Vertex Medical Corp.	DRE	Class II	1982-09-28
K822594	Polyethylene Cardiovascular Catheter	Vertex Medical Corp.	DQO	Class II	1982-09-28
K822593	Percutaneous Catheter Introducer Set	Vertex Medical Corp.	DYB	Class II	1982-09-28
K822585	Lithotriptor Electrode 4.5F	Monaghan Medical Corp.	FFK	Class II	1982-09-28
K822565	Needle Catheter Jejunostomy Kit	Bio-Research Associates, Inc.	KNT	Class II	1982-09-28
K822536	Mark V	Medrad, Inc.	DXT	Class II	1982-09-28
K822531	Multiple, ENT Cabinet #448	Midmark Corp	ETF	Class I	1982-09-28
K822522	Cutaneous Pressure Plethysmograph	Life Sciences Manufacturing, Inc.	DSB	Class II	1982-09-28
K822520	Model Ucg Assay	Monoclonal Antibodies, Inc.	JHI	Class II	1982-09-28
K822509	Covalent Coat Ria Kit	Immuchem Corp.	CFP	Class I	1982-09-28
K822452	Protemp	Espe GmbH (US)	EBG	Class II	1982-09-28
K822420	Replam Hydroxyapatatite	Replam Corp.	FMF	Class II	1982-09-28
K822265	Fiberoptic Light Source W/related Items	Kelleher Corp.	EBA	Class I	1982-09-28
K822030	Multiple Lead Arrhythmia Module	Marquette Electronics, Inc.	DSI	Class II	1982-09-28
K821772	Surgita/mizho Microneurosurgery Head Fr	Downs Surgical, Ltd.	HBL	Class II	1982-09-28
K822743	Solid State Continuous Flow Control	Widran Urological Group, Ltd.	LJH	Class II	1982-09-24
K822738	Triex-Ih Dialyzer	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1982-09-24
K822732	Lineguard Catheter Shield Model 100	Ray-Marshall Laboratory	KMK	Class I	1982-09-24
K822600	Neuromedics Orions #660-01	Intermedics, Inc.	GZJ	Class II	1982-09-24
K822502	Disposable Thermometers	Hudson Oxygen Therapy Sales Co.	FLK	Class II	1982-09-24
K822455	Vasograph, Model Mv-2	Electro-Diagnostic Instruments	DSB	Class II	1982-09-24
K822396	The 3500	Tracor Northern, Inc.	GWF	Class II	1982-09-24
K822307	Adhesive Spray #4050-4060	The Healthcare Group Laboratories, Inc.	KNX	Class II	1982-09-24
K822217	Thermotherapy	Luther Medical Products, Inc.	LKX	Unclassified	1982-09-24
K822214	Cadwell 7400	Cadwell Laboratories, Inc.	GWF	Class II	1982-09-24
K821818	Retrieval Balloons	American Endoscopy, Inc.	KOD	Class II	1982-09-24
K821492	Be#6006 Var. Resis. Inspir. Muscle	Instrumentation Industries, Incorporated	BWF	Class II	1982-09-24