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 2026-11-05, 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 2362 of 3531

510(k) clearances, page 2362 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922904	Rai-Trol Fructosamine Serum Controls I and II	Reagents Applications, Inc.	JJX	Class I	1992-07-30
K922792	Zithromax	Difco Laboratories, Inc.	JNT	Class I	1992-07-30
K922614	Turkel Thoracentesis System	Boston Scientific Corporation	GAA	Class I	1992-07-30
K922499	Reflections - Ceramic Dental Bracket	Cdb Corp.	EJF	Class I	1992-07-30
K922354	Byrd Telescoping Stainless Steel Dilat Sheath Set	Med Institute, Inc.	GCC	Class I	1992-07-30
K922310	Vortech's Personal Display System	Vortech Data, Inc.	LLZ	Class II	1992-07-30
K922184	Hp Sonos 100 Cf Ultrasound Imaging System	Hewlett-Packard Co.	ITX	Class II	1992-07-30
K922032	Enzip Urinary Microalbumin Test	Diagnostic Specialties	JIR	Class I	1992-07-30
K922008	Cdh Hip System	Howmedica, Pfizer Medical Technology Group	JDI	Class II	1992-07-30
K921860	Modification to IV Spike	Mcgaw, Inc.	FPA	Class II	1992-07-30
K921745	Hybritech Stratus Pap Fluorometric Enzyme Immuno	Hybritech, Inc.	JFH	Class II	1992-07-30
K921461	Turkel Thoracentesis Needle	Boston Scientific Corporation	GSS	Class II	1992-07-30
K921403	Model 654 Analyzer	Ciba Corning Diagnostics Corp.	JIH	Class II	1992-07-30
K921167	Ultrablade	Micron Technology, Inc.	GDX	Class I	1992-07-30
K921062	Gaeltec Mpr Series	Medical Measurements, Inc.	FFX	Class II	1992-07-30
K920861	Woodlyn Classic Lensmeter	Woodlyn, Inc.	HLM	Class I	1992-07-30
K920536	Affirm Vp Sample Collection Set	Microprobe Corp.	LIO	Class I	1992-07-30
K920441	3D Tof Angiography Measuring Function	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1992-07-30
K920437	Synthetic Absorbable Suture, Undyed	Ethicon, Inc	GAW	Class II	1992-07-30
K915757	Models M1722a, M1723a, M1724a Defibrillators	Hewlett-Packard Co.	DRO	Class II	1992-07-30
K915700	Permier Histoplasma	Meridian Diagnostics, Inc.	MIZ	Class II	1992-07-30
K915678	Merit Administration Set	Merit Medical Systems, Inc.	FPA	Class II	1992-07-30
K914878	Zirconium Alloy Frmoral Head	Smith & Nephew Richards, Inc.	JDI	Class II	1992-07-30
K914005	Fiberoptic Tympanic Thermometer, Model 6000	Daily Medical Products, Inc.	FLL	Class II	1992-07-30
K913624	Medrad Mct-Plus Injector	Medrad, Inc.	DXT	Class II	1992-07-30
K911356	Legionella Stat Igg/igm Test Kit	Whittaker Bioproducts, Inc.	MJH	Class II	1992-07-30
K922006	Qquadrature Lumbar Contour Coil	Magnetic Research, Inc.	LNH	Class II	1992-07-29
K920324	Itc Bunji Coil (Modification)	Interventional Therapeutics Corp.	HCG	Class II	1992-07-29
K920005	Il Test Alpha-1-Antitrypsin (Aat)	Instrumentation Laboratory Co.	DEM	Class II	1992-07-29
K915845	Hair Tronics Model Ht8000	Global Tronics Intl., Inc.	KCX	Class I	1992-07-29
K915829	Il Test(tm) Haptoglobin (Hpt)	Instrumentation Laboratory Co.	DAD	Class II	1992-07-29
K922885	Olympus Aspartate Aminotransferase Reagent	Olympus Corp.	CIT	Class II	1992-07-28
K922884	Olympus Alanine Aminotransferase Reagent	Olympus Corp.	CKA	Class I	1992-07-28
K922794	Enoxacin	Difco Laboratories, Inc.	JTN	Class II	1992-07-28
K922793	Cefzil	Difco Laboratories, Inc.	JTN	Class II	1992-07-28
K922791	Loracarbef 30Mcg Disk	Difco Laboratories, Inc.	JTN	Class II	1992-07-28
K922563	Life-Tel L.b.e. (Life-Pak 5 Battery Eliminator)	Raco Products Co.	LDD	Class II	1992-07-28
K922168	Antimicrobial Susceptibility Test Panel	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1992-07-28
K922151	Wako Autokit RF	FUJIFILM Healthcare Americas Corporation	DHR	Class II	1992-07-28
K922085	Monoclonal Antibody Igg2a Isotype Cont. Flow Cytom	Gen Trak, Inc.	GKZ	Class II	1992-07-28
K922084	Monomclonal Antibody Igg1 Isotype Cont. Flow Cytom	Gen Trak, Inc.	GKZ	Class II	1992-07-28
K922001	Spectacle Frames	Otego Optical, Inc.	HQZ	Class I	1992-07-28
K922000	Model #Qsc-200, 20Cm. Quadrature Shoulder Coil	Mri Devices Corp.	LNH	Class II	1992-07-28
K921787	Synelisa Tpo Antibodies	Elias U.S.A., Inc.	JNL	Class II	1992-07-28
K921421	Legionella Reagens for Direct Fluorescent Antibody	Pro-Lab, Inc.	LHL	Class II	1992-07-28
K921302	Vitek Immunodiagnostic Assay System	Vitek Systems, Inc.	JHI	Class II	1992-07-28
K921180	Cobas Core Immunochemistry System	Roche Diagnostic Systems, Inc.	JJQ	Class I	1992-07-28
K921118	Acs Apct Reagent	Analytical Control Systems	GFO	Class II	1992-07-28
K921096	Laser-6	Laser Endo Technic	GEX	Class II	1992-07-28
K921006	Laparoscopic Retractor System	Laparomed Corp.	GCS	Class II	1992-07-28