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 3210 of 3528

510(k) clearances, page 3210 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822176	Microsurgical Ear Picks	Kelleher Corp.	JYT	Class I	1982-08-16
K822168	Antrum Trocars	Kelleher Corp.	KTE	Class I	1982-08-16
K822165	ENT Chisels	Kelleher Corp.	JYE	Class I	1982-08-16
K822162	Myringotomy Knife (Various Types)	Kelleher Corp.	JYP	Class I	1982-08-16
K822136	Laser Bronchoscope	Laser Industries of Tel Aviv	EOQ	Class II	1982-08-16
K822116	Anesthesia Breathing Bag, Various Sizes	Life Design Systems, Inc.	BTC	Class I	1982-08-16
K822094	Dental Matrix Band	Dentsply Intl.	DZN	Class I	1982-08-16
K822083	U-100 Insulin Syringe	Terumo Medical Corp.	FMF	Class II	1982-08-16
K822065	Kam Sucker	The Anspach Effort, Inc.	KDC	Class I	1982-08-16
K822049	Lundia 10-5 N Parallel Flow Dialyzer	Gambro, Inc.	KOC	Class II	1982-08-16
K822032	Large Volume Closed Wound Suction Drain	American Heyer Schulte	GCY	Class I	1982-08-16
K821997	Medi + Bio Safe Steam Steriliz. Indicat	Arvey Corp.	JOJ	Class II	1982-08-16
K821982	Titan Gel Serum Control	Helena Laboratories, Corp.	JJY	Class I	1982-08-16
K821936	Critikon Oxygen Monitor, Model 8030	Critikon Company, LLC	KLK	Class II	1982-08-16
K821930	Sechrist Model 990 Jet Ventilator	Sechrist Industries Inc	CBK	Class II	1982-08-16
K821823	i.v. Sentinel	The John Bunn Co.	FLN	Class II	1982-08-16
K821765	Phototherapy Eye Protection for Infants	Russell Terry Co.	HOY	Class I	1982-08-16
K821556	Exacon Temp. Probes System 8000-#Th-103	Sat Export Engineering & Trading	FLL	Class II	1982-08-16
K821555	Exacon Thermometer System 8000	Sat Export Engineering & Trading	FLL	Class II	1982-08-16
K821511	Powered Muscle Stimulator	High Country Ent.	EPF	Class II	1982-08-16
K822395	Cf 1211 Capillary Flow Dialyzer Code	Travenol Laboratories, S.A.	FJH	Class II	1982-08-12
K822229	Primidone Fluorescent Immunoassay	American Diagnostic Corp.	LFT	Class II	1982-08-12
K822149	Gilchem Y-Gt Reagent	Gilford Diagnostics	JPZ	Class I	1982-08-12
K822027	i.v. Administration Set	Baker & Hostetler	FPA	Class II	1982-08-12
K822011	Shea's Ear Speculum Holder Port Manns	Kelleher Corp.	JYK	Class I	1982-08-12
K822010	Rigid Suction Tips & Related Items	Kelleher Corp.	JZF	Class I	1982-08-12
K822008	Torx or Type Micro Motor Handpiece	Kelleher Corp.	ERL	Class II	1982-08-12
K822007	Bone Rongeuns ENT & Related Items	Kelleher Corp.	JZA	Class I	1982-08-12
K822006	Operative Ear Currettes & Related Item	Kelleher Corp.	JYG	Class I	1982-08-12
K821993	Shiley Laryngectomy Tube	Shiley, Inc.	KAC	Class I	1982-08-12
K821991	Danavos Custom Ear	Deravox, Inc.	ESD	Class I	1982-08-12
K821849	Ebv-Vca Antibody Assay Kit	Biotech Research Laboratories, Inc.	JRY	Class I	1982-08-12
K821752	Synthograft Lg-Augmentation & Bone Fill	Depuy, Inc.	LYC	Class II	1982-08-12
K821685	Tom's Naturally Waxed Flossing Tape	Tom's of Maine, Inc.	JES	Class I	1982-08-12
K822164	Ear Speculi	Kelleher Corp.	EPY	Class I	1982-08-11
K822163	ENT Retractors	Kelleher Corp.	ESD	Class I	1982-08-11
K822108	Cement-Pick	Bio-Blitz, Inc.	GAF	Class I	1982-08-11
K827762	Radiographic Film Illuminator	Brandt Industries, Inc.			1982-08-10
K827761	Med-X Model 301 X-Ray Filter	Bfi- Medical Waste Systems			1982-08-10
K827760	Digital Fluorographic X-Ray System	General Electric Co.			1982-08-10
K827713	Scanner 560 Ultrasound Scanner	Pie Data, Inc.			1982-08-10
K822112	Ophthalmic Knife	Sharpoint, Inc.	HNN	Class I	1982-08-10
K822104	Alcon Indirect Ophthalmoscope	Alcon Laboratories	HLI	Class II	1982-08-10
K822082	Sheridan/hvt,cf, Uncuffed	Sheridan Catheter Corp.	BTR	Class II	1982-08-10
K821974	Pentax Choledochofiberscope, #Fcd-15A	Pentax Precision Instrument Corp.	FBN	Class II	1982-08-10
K821848	Assure-Male External Incontince Catheter	Medical Design & Manufacturing Corp.	KNX	Class II	1982-08-10
K821825	Conphar Silicone Feeding Tube	Conphar, Inc.	KNT	Class II	1982-08-10
K821817	Pigtail Nasal Catheters	American Endoscopy, Inc.	FGE	Class II	1982-08-10
K821776	Surgitek Percutaneous Nephrost. Stent	Medical Engineering Corp.	LJE	Unclassified	1982-08-10
K821628	The Inflatable Penile Prosthesis	American Medical Systems, Inc.	FAE	Class II	1982-08-10