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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2758 of 3530

510(k) clearances, page 2758 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874893	Model 35300 Tracker(tm) Therapy Beam Evaluator	Keithley Instruments, Inc.	IYE	Class II	1988-02-17
K874860	Acuson I7505 Transducer for Intracavitary Applica.	Acuson Computed Sonography	ITX	Class II	1988-02-17
K874830	Miracle Ear Model Bp Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1988-02-17
K874802	Flipscreen Qat	Alerchek, Inc.	DHB	Class II	1988-02-17
K874776	Acs 0.025-in Hi-Torq Modif J/stand Telesc Guidewir	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-02-17
K874633	Permcath Insertion Tray	Quinton, Inc.	LFJ	Class II	1988-02-17
K874619	Spectron Ef Acetabular Component	Richards Medical Co., Inc.	JDI	Class II	1988-02-17
K874541	Rrt Total Ige Test Kit	Incstar Corp.	DGC	Class II	1988-02-17
K873331	Ortho. Gas Insufflator Model in-2 for Arthro. Surg	Directed Energy, Inc.	HRX	Class II	1988-02-17
K880425	Sterling (Motorized Vehicle)	A-Bec Mobility, Inc.	INI	Class II	1988-02-16
K880424	Scoota Bug (Motorized Vehicle)	A-Bec Mobility, Inc.	INI	Class II	1988-02-16
K880423	Targa (Wheelchair)	A-Bec Mobility, Inc.	ITI	Class II	1988-02-16
K880376	Novo Vivo Suction Catheter Vessel W/mucose Trap	Genesis Industries, Inc.	GBS	Class I	1988-02-16
K880355	Model 938 Bathing System	Ferno Ille-Forge	ILJ	Class II	1988-02-16
K880350	Yue/fa Disposable Syringe	Honway International Co.	FMF	Class II	1988-02-16
K880340	Modified Air Fluidized Bed, Kinair	KCI USA, Inc.	INX	Class II	1988-02-16
K880336	Mobilimb Hand C.p.m. Unit	Toronto Medical Corp.	JFA	Class I	1988-02-16
K880174	Jms Transfusion Set	JMS Co., Ltd.	BRZ	Class II	1988-02-16
K880046	Hasting Finger Fixator Instruments	Buckman Co., Inc.	HXY	Class I	1988-02-16
K875349	Sterile Surgical Natural Latex Gloves	Marand Products, Inc.	KGO	Class I	1988-02-16
K875186	IV Extension Set	Marquette Medical, Inc.	FPK	Class II	1988-02-16
K875155	60 Ml Reservoir Bag, Item #200	Prn Services, Inc.	KPE	Class II	1988-02-16
K875105	Technicon Smac 3 System	Technicon Instruments Corp.	JJC	Class I	1988-02-16
K875097	Disposable Syringe	California Ent.	FMF	Class II	1988-02-16
K874863	Ramp Herpes Simplex Virus (Hsv) (Cct)	Monoclonal Antibodies, Inc.	GQN	Class II	1988-02-16
K874836	Abuscreen(r) Eia Amphetamine	Roche Diagnostic Systems, Inc.	DKZ	Class II	1988-02-16
K874805	Tatung's Denture Cleaning Solution	Tatung Company of America, Inc.	EFT	Class I	1988-02-16
K874719	Stratum Esu	Alternative Design Systems, Inc.	JOS	Class II	1988-02-16
K874623	Fiagen(tm) Thyroxine (T4), Catalogue #101-101	Cyberfluor, Inc.	CDX	Class II	1988-02-16
K874495	Adcomp 4000 Hp System	Healthtek, Inc.	LHI	Class II	1988-02-16
K874328	L-Phenylalanine Methyl Ester Hydrochloride Pme Rea	E.I. Dupont de Nemours & Co., Inc.	JCF	Class I	1988-02-16
K880262	Mobile Pak, Model Dc	Intl. Biomedical Concepts, Inc.	CAW	Class II	1988-02-12
K880261	Mobile Pak, Model Ac	Intl. Biomedical Concepts, Inc.	CAW	Class II	1988-02-12
K880247	Modified Shiley Low Pressure Cuffed Tracheo. Tubes	Shiley, Inc.	BTO	Class II	1988-02-12
K875380	Shimadzu Catheterization C-Arm Stand Mh-10	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875379	Shimadzu Cerebral Angiographic Unit Er-100A	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875377	Shimadzu Mammographic Stand Mr-30	Shimadzu Precision Instruments, Inc.	IZH	Class II	1988-02-12
K875376	Shimadzu Catheterization C-Arm Stand Mh-50B	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875375	Shimadzu Lateral C-Arm Mh-30	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875374	Shimadzu Ceiling-Suspended C-Arm Ch-50	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875373	C-Arm Stand for Biplance Cine Fluorography Mh-20	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875372	Shimadzu Catheterization C-Arm Stand Er-200	Shimadzu Precision Instruments, Inc.	IZI	Class II	1988-02-12
K875269	Acs Soft-Tip Coronary Infusion Catheter W/sidehole	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1988-02-12
K875059	Disposable Bipolar Temporary Pacing Electrode	Daig Corp.	LDF	Class II	1988-02-12
K875058	Sterile Mucus Specimen Trap, Models 406 & 407	Busse Hospital Disposables	BSY	Class I	1988-02-12
K875031	Oxygen/pulse Monitor	Healthdyne, Inc.	DQA	Class II	1988-02-12
K875023	Biosurge Model Oasys-II	Biosurge, Inc.	CAC	Class II	1988-02-12
K874947	Model 8800 Cardiorespiratory Oximeter	Nonin Medical, Inc	DQA	Class II	1988-02-12
K874908	C900 X-Ray Film Processor	Summit Industries, LLC	IXW	Class II	1988-02-12
K874751	Tracker-25 Infusion Catheter	Target Therapeutics	DQY	Class II	1988-02-12