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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2421 of 3531

510(k) clearances, page 2421 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904893	Fiax Lyme M Test Kit	Whittaker Bioproducts, Inc.	LSR	Class II	1991-10-16
K913745	Ducal Side Shield Sunglass	Ducal Trading Corp.	HQY	Class I	1991-10-15
K913619	Ceravital Middle Ear Implant	Friedrichsfeld Medizintechnik AG	ETB	Class II	1991-10-15
K913478	Radiographic Film Marking System	Lorad Medical Systems, Inc.	JAC	Class I	1991-10-15
K913461	Fastlok (Staple & Buckle) Fixation System	Neoligaments, Ltd.	JDR	Class II	1991-10-15
K913189	Nidek Model Nt-1000	Nidek, Inc.	HKX	Class II	1991-10-15
K913148	Collagen Shield for Acute Care	Vitaphore Corp.	MOE	Class I	1991-10-15
K913029	Gyroview-Hr	Philips North America LLC	JAK	Class II	1991-10-15
K912933	Medicam Laparoscopy Endoscopes	Kirschner Medical Corp.	GCJ	Class II	1991-10-15
K912763	Ohmeda Style Check Units (Female Couplers)	Medical Fittings, Inc.	BYX	Class I	1991-10-15
K912710	True/flex Tibial Rods with Cap	Applied Osteo Systems, Inc.	HSB	Class II	1991-10-15
K912684	Home Medical Kit - for Little Hurts	Great West Medical Equipment, Inc.	MCY	Class II	1991-10-15
K912412	Vitalograph Spirotrac III	Vitalograph, Inc.	BZG	Class II	1991-10-15
K912033	Ultrasound Stethoscope(r) Intradop(r)	Medadonics, Inc.	JAF	Class II	1991-10-15
K911983	Wizard Sterilized Electroepilation Needle	Skin Deep, Inc.	KCW	Class I	1991-10-15
K911888	Philips Angiopro	Philips North America LLC	IZP	Class II	1991-10-15
K911814	Axion 5, Modification	Ventura Medical Electronics	GZJ	Class II	1991-10-15
K911770	Optimol Respiratory Humidification System	Automatic Liquid Packaging, Inc.	BTT	Class II	1991-10-15
K911750	Computer Assist Stereotactic Surg Syst, Modified	Medical Instrumentation & Diagnostics Corp.(Midco)	IYE	Class II	1991-10-15
K911598	Datascope Passport Monitor	Datascope Corp.	DRT	Class II	1991-10-15
K910970	Marksman Arterial Blood Gas Syringe	Martech Medical Products	JKA	Class II	1991-10-15
K910421	Saturation/hematocrit Monitor System	Medtronic, Inc.	DRY	Class II	1991-10-15
K905672	Team-Mc	Henley Intl.	GZJ	Class II	1991-10-15
K904360	Challenge 4010 One Channel Wide Pulse Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1991-10-15
K914333	Siemens Model Ls-I W/infiniti Programmable Option	Siemens Hearing Instruments, Inc.	ESD	Class I	1991-10-11
K914303	Target(tm)-Hog	V-Tech, Inc.	JHI	Class II	1991-10-11
K914262	Abbott Quickstart Ldh,#5a31	Em Diagnostic Systems, Inc.	CFJ	Class II	1991-10-11
K914253	Proclinic One Step Pregnancy Test	Vanguard Biomedical Corp.	JHI	Class II	1991-10-11
K914202	Bartels Prima System Advanced Screening Cartridge	Baxter Diagnostics, Inc.	JJQ	Class I	1991-10-11
K914146	Biosite Diagnostics-Triage Panel for Drugs Abuse	Biosite Incorporated	DKZ	Class II	1991-10-11
K914129	Diff Safe	Marshall Levinson	JKA	Class II	1991-10-11
K913927	Il Bg3 Syst, Model 1420, Blood Gas & Ph Test Syst	Instrumentation Laboratory Co.	CHL	Class II	1991-10-11
K913864	Pcp Direct Ria Kit (I-125)	Immunalysis Corporation	LCL	Unclassified	1991-10-11
K913506	Convertors Safecare Gown & Drape Material	Baxter Healthcare Corporation	KKX	Class II	1991-10-11
K913456	Visi-Neisseria	Kev Connecticut Diagnostics, Inc.	JSX	Class I	1991-10-11
K913307	Abbott Quickstart Total Bilirubin (Tbil) #5A21	Em Diagnostic Systems, Inc.	CIG	Class II	1991-10-11
K913225	Urine/csf Microprotein Reagent	Intersect Systems, Inc.	CEK	Class II	1991-10-11
K913221	Type Fa10 Audiometer	Frye Electronics, Inc.	EWO	Class II	1991-10-11
K913208	Apr II Non-Porous Hip Stem	Intermedics Orthopedics	JDI	Class II	1991-10-11
K913188	Kinemax Plus Tibial Insert	Howmedica Corp.	JWH	Class II	1991-10-11
K913060	Natural Porous Hip System	Intermedics Orthopedics	JDI	Class II	1991-10-11
K912703	Optica 60 Nd;yag Surgical Laser System	Xintec Corporation	GEX	Class II	1991-10-11
K912370	Hap Bio-Groove Total Hip Prosth (Bio-Interfaces)	Zimmer GmbH	MEH	Class II	1991-10-11
K912369	Hap Bio-Groove Total Hip Prosthesis (Bio-Coat)	Zimmer GmbH	MEH	Class II	1991-10-11
K912344	Modified Duraphase(tm) Implanted Penile Prosthesis	Dacomed Corp.	FAE	Class II	1991-10-11
K912330	B-D(tm) Microfine(tm) IV Pen Injector Cat. #328204	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1991-10-11
K912255	Hycor Pyloragen Helicobacter Pylori Test	Hycor Biomedical	LYR	Class I	1991-10-11
K912107	Gore-Tex Expanded Poly. Card. Patch 0.6 and 0.4Mm	W. L. Gore & Associates, Inc.	DXZ	Class II	1991-10-11
K911925	Polaris, Gastroenterology/urology/pulmonary, Gi/gu	Pfizer Laser Systems	GEX	Class II	1991-10-11
K910687	Guardian Gel, Surgeon's Gloving Cream	Guardian Angel Products, Inc.	KGQ	Class I	1991-10-11