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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2952 of 3529

510(k) clearances, page 2952 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853274	American Dilatation System	American Endoscopy, Inc.	KNQ	Class II	1985-10-17
K853172	International Model Sc Canal in the Ear Hearing Ai	Int'L Hearing Aids, Inc.	ESD	Class I	1985-10-17
K853128	Sarns Evacuplege Catheter	3M Health Care, Sarns	DWF	Class II	1985-10-17
K852928	Virogen Herpes Slide Test	Armkel, LLC	GQO	Class II	1985-10-17
K852856	Laborie Urodynamics Processor	Tridak Division of Indicon, Inc.	FAP	Class II	1985-10-17
K852552	Coons Gastrostick System	Medi-Tech, Inc.	KNT	Class II	1985-10-17
K852535	E-Z P.e.g. W/percutaneous Endoscopy Gastrostomy	Tri-Med Specialties, Inc.	KNT	Class II	1985-10-17
K852467	Vial Vent Filter	Baxter Healthcare Corporation	LHI	Class II	1985-10-17
K851486	Gould Disposable Transducer & Accessories-Dtx	Gould, Inc.	DRS	Class II	1985-10-17
K850884	Argyle Polyurethane Umbilical Vessel Catheter	Sherwood Medical Co.	FOS	Class II	1985-10-17
K844999	Phadebact Csf Test	Pharmacia, Inc.	GTJ	Class II	1985-10-17
K853984	Canon X-Ray Image Distributor	Canon Medical Components U.S.A., Inc.	JAA	Class II	1985-10-16
K853983	Canon X-Ray 35Mm Cine Camera Csi-35	Canon Medical Components U.S.A., Inc.	IZJ	Class II	1985-10-16
K853973	Wescor Model 3700 Webster Sweat Inducer	ELITechGroup Inc	KTB	Class II	1985-10-16
K853949	Demand Acid Phosphatase Reagent	Cooper Biomedical, Inc.	CKB	Class II	1985-10-16
K853948	Minnesota Scientific, Inc. Omni-Beam	Minnesota Scientific, Inc.	HBI	Class II	1985-10-16
K853947	Omni-Tract Chest Wall & Luna Retractor	Minnesota Scientific, Inc.	GAD	Class I	1985-10-16
K853927	Lase System II	James L. Geraci & Associates, Inc.			1985-10-16
K853905	Ohmeda Oxygen Blender	GE Healthcare	BZR	Class II	1985-10-16
K853880	Attends Dispos. Underpad	Procter & Gamble Mfg. Co.	KME	Class I	1985-10-16
K853857	V-Trend Aso Plus Latex Test	Texas Immunology, Inc.	GTQ	Class I	1985-10-16
K853838	Jms Lcc Insulin Syringe	JMS Co., Ltd.	FMF	Class II	1985-10-16
K853837	Lh/fsh Radioimmunoassay Kit	Bioclinical Group	CEP	Class I	1985-10-16
K853820	Surgical Tapes Cloth, Paper & Plastic-Base	Abco Dealers, Inc.	KGX	Class I	1985-10-16
K853794	Neoguard Reflector	Cas Medical Systems, Inc.	FMT	Class II	1985-10-16
K853786	Oxygen Monitor Om-100 & Oxygen Probe Op-100	American Bentley	CCE	Class II	1985-10-16
K853515	Pee Wee Thermometers	Joel R.L. Ehren Kranz	FQZ	Class I	1985-10-16
K853447	Polycarb Water Set	Pulpdent Corp. of America	EMA	Class II	1985-10-16
K853437	H-H Hunter Tendon Rod	Holter-Hausner Intl.			1985-10-16
K853436	H-H Hunter Passive Tendon Implant	Holter-Hausner Intl.	HXR	Class I	1985-10-16
K853251	J & J Cardiovascular Maxima Hollow Fiber Oxygenato	Johnson & Johnson Professionals, Inc.	DTZ	Class II	1985-10-16
K853245	Tracor Model Ra600 Microprocessor Audiometer	Tracor Instruments, Inc.	EWO	Class II	1985-10-16
K853183	Endodontic Electronic Spreader Heater	Sturgeon Engineering Co.	EKK	Class I	1985-10-16
K853155	Boehringer Lab Suction Interrupter	Boehringer Laboratories, LLC	KDP	Class II	1985-10-16
K853144	Card Three Im Test Item #2035, Card One Im #2036	Preco, Inc.	KTN	Class II	1985-10-16
K853143	Cooper Laser Sonics Cusa Model 200	Cooper Lasersonics, Inc.	LBK	Unclassified	1985-10-16
K853087	Storz Solid-Standoff Pachymetry Probe	Storz Instrument Co.	IYO	Class II	1985-10-16
K853075	Mednova Safety Bag	Mednova Corp.	LHI	Class II	1985-10-16
K852977	Knee Machine	Kaiser Medical Inc	BXB	Class I	1985-10-16
K852901	Double Puncture Instruments	L.A.S.E.R., Inc.	HET	Class II	1985-10-16
K852444	Asik 'Once' Syringe	Pharma-Plast USA, Inc.	FMF	Class II	1985-10-16
K852443	Pharma-Plast Clinipak	Pharma-Plast USA, Inc.	FMF	Class II	1985-10-16
K852333	Downs Vpap Circuit	Vital Signs, Inc.	CAN	Class I	1985-10-16
K852305	Flexiroot	Facial Alveodental Implant Rehabilitation, Inc.	DZE	Class II	1985-10-16
K851977	Hem Ave-Toxo Titration Hemagglutination Test Kit	Si Sero-Immuno Diagnostics, Inc.	GMM	Class II	1985-10-16
K851976	Hem Ave-Toxo Screening Hemagglutination Test Kit	Si Sero-Immuno Diagnostics, Inc.	GMM	Class II	1985-10-16
K851733	Dental Porcelain-Various	Excelco Intl., Inc.	ELL	Class II	1985-10-16
K850895	Ventrezyme, Vast Immunoperoxidase Assay	Ventrex Laboratories, Inc.	DHB	Class II	1985-10-16
K850803	Nail Splint	Inro Medical Designs, Inc.	MQZ	Unclassified	1985-10-16
K850417	Interface Modules Im 1000 Image Communi-Network	Impact Systems Corp.	LMD	Class I	1985-10-16