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 3199 of 3528

510(k) clearances, page 3199 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822185	Laryngeal Syringe	Kelleher Corp.	FMF	Class II	1982-10-18
K822115	Seragan Acth125 I-Ria Kit	Seragen Diagnostics, Inc.	CKG	Class II	1982-10-18
K822091	Siemens Sirecust System	Analogic Corp.			1982-10-18
K821992	Alpha-Toxin Discs	Microchemical Specialities, Co.	JTO	Class I	1982-10-18
K821989	Non-Stetho 7, Um-15Tp	Hirata Sangyo Co. USA, Inc.	DXN	Class II	1982-10-18
K821863	Dialyzer Reprocessing System Drs-4	Seratronics, Inc.	LIF	Class II	1982-10-18
K820882	Pecor, Percor-Dl, 10.5 French W/smec	Datascope Corp.	DSP	Class II	1982-10-18
K822906	Physical Medicine & Rehabilitation Equip	I-Rep, Inc.	ION	Class I	1982-10-15
K822904	Model 325D Unipolar Cardiac Pulse Gen	Cook Pacemaker Corp.	DXY	Class III	1982-10-15
K822854	Pro Med 100	Rebco Trading Co.	GZJ	Class II	1982-10-15
K822848	Primary & Secondary i.v. Tubing Sets	David Simmonds Co., Inc.	FPA	Class II	1982-10-15
K822836	Microflex-Venoflux	Exco, Inc.	FPA	Class II	1982-10-15
K822798	Disposable Electrode #1900	Andover Medical, Inc.	DRX	Class II	1982-10-15
K822789	Roomate II	Cryogenic Assoc.	CAW	Class II	1982-10-15
K822723	Swan-Ganz Bipolar Pacing Catheter	American Edwards Laboratories	DYG	Class II	1982-10-15
K822695	Signal Distribution Network #78581A	Hewlett-Packard Co.	DRT	Class II	1982-10-15
K822692	Digital Pulse Meter (73 Bws) #Hrm-100E	Sanyo Electric, Inc.	DRT	Class II	1982-10-15
K822691	Vygon Epidural Anaesthesia Tray	Exco, Inc.	CAZ	Class II	1982-10-15
K822080	Adhesive Wound Cover Film	Hollister, Inc.	NAD	Class I	1982-10-15
K822003	Balloon Temp. Pacing Catheter	Ziehm International, Inc.	LDF	Class II	1982-10-15
K822002	Bipolar Temp. Pacing Catheter W/styletet	Ziehm International, Inc.	LDF	Class II	1982-10-15
K821507	Symptotherm 8 Fertility Indicator	Ovix Corp., Inc.	LHD	Unclassified	1982-10-14
K822875	Pedi-Tube Pediatric Feeding Tube	Biosearch Medical Products, Inc.	KNT	Class II	1982-10-13
K822869	Command Bonding Resin/glaze/opaquer	Sybron Corp.	EBD	Class II	1982-10-13
K822805	Hearing Aid, Unitron Model Ue7	Unitron Industries, Inc.	ESD	Class I	1982-10-13
K822746	Rt-200 Calibration Analyzer	Timeter Instrument Corp.	BXX	Class I	1982-10-13
K822724	Suction Tubes	Exco, Inc.	BSY	Class I	1982-10-13
K822710	Metabolic Measurement Cart	Beckman Instruments, Inc.	BZL	Class II	1982-10-13
K822705	Tamdem-R Thyroid Stimulating Hormone Kit	Hybritech, Inc.	JLW	Class II	1982-10-13
K822625	Syntevent Atomizer/nebulizer Aerosol	Syva Co.	CCQ	Class I	1982-10-13
K822623	Laparotomy Sponge	Hermitage Hospital Products, Inc.	GDY	Class I	1982-10-13
K822591	Tissue Forceps	Medcare Products	GEN	Class I	1982-10-13
K822574	Innomed Pd-1 Kit	Innomed, Inc.	LJL	Class I	1982-10-13
K822551	Amp Capd Unispike Aministration Set	American Medical Products LLC	FKK	Class I	1982-10-13
K822550	Safe Lock Titanium Adapter Set	American Medical Products LLC	FKX	Class II	1982-10-13
K822549	Ccpd Cycler Set W/5 Pronged Safe Lock	American Medical Products LLC	FKX	Class II	1982-10-13
K822548	Safe Lock Catheter S-3	American Medical Products LLC	FKX	Class II	1982-10-13
K822546	Safe Lock Sealing Caps	American Medical Products LLC	FKX	Class II	1982-10-13
K822545	Ccpd Cycler Set W/5 Pronged Connector	American Medical Products LLC	FKX	Class II	1982-10-13
K822544	Safe Lock Sealing Cap L	American Medical Products LLC	FKX	Class II	1982-10-13
K822543	Capd Safe Lock Transfer Set	American Medical Products LLC	FKX	Class II	1982-10-13
K822529	Special Eye Mirror	Wilmington Optics, Inc.			1982-10-13
K822519	Hawkins Eba -16 Muscle Stimulator	A-Zenith Therapeutic Equipment/Supply	IPF	Class II	1982-10-13
K822510	Suction Catheter W/sterile Water	Medine Dynacor	GBX	Class I	1982-10-13
K822439	Acufex Magnetic Retriever	Acufex Microsurgical, Inc.			1982-10-13
K822423	Baby Temp Pacifier	Trp Energy Sensors, Inc.	FQZ	Class I	1982-10-13
K822421	Innocomb Lice Comb	Innovative Products, Inc.	LJL	Class I	1982-10-13
K822385	Extrapure Reverse Osmosis Water Unit	Extracorporeal Medical Specialities, Inc.	FIP	Class II	1982-10-13
K822287	Bx-500 Electronic Muscle Exerciser	Bloomex International, Inc.	IPF	Class II	1982-10-13
K822267	Transformer	Kelleher Corp.			1982-10-13