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 1776 of 3531

510(k) clearances, page 1776 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984318	Architect Fsh Mastercheck, Model Number 6C24-05	Bio-Rad	JJX	Class I	1998-12-15
K983769	Distaflo Bypass Graft	Impra, Inc.	DYF	Class II	1998-12-15
K983601	Demand Oxygen Conserving Device, Docd, the Doc	Medical Electronic Devices, Inc.	NFB	Class II	1998-12-15
K983556	Abuscreen Online Benz 300 Calibrators	Roche Diagnostic Systems, Inc.	DLJ	Class II	1998-12-15
K983555	Abuscreen Online Benz 200 Calibrators	Roche Diagnostic Systems, Inc.	DLJ	Class II	1998-12-15
K983498	Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to as Bard Lubricious Ureteral Ste	C.R. Bard Inc	FAD	Class II	1998-12-15
K983401	Framewave Web	Ml Strategies, Inc.	LLZ	Class II	1998-12-15
K983392	Data Ray Corporation Dr11021 Medical Imaging Monitor	Data Ray	LLZ	Class II	1998-12-15
K983256	Advantage Windows (Aw) Fusion	GE Healthcare	LLZ	Class II	1998-12-15
K981992	Electron Wedge Model Mt-Ew-1000	Medtec LLC	IXI	Class II	1998-12-15
K973718	Roche Cobas Amplicor Ct/ng Test for Chlamydia Trachomatis	Roche Molecular Systems Inc	MKZ	Class I	1998-12-15
K984372	Elecsys Calcheck Troponin T	Boehringer Mannheim Corp.	JJY	Class I	1998-12-14
K984225	Liquichek Serum Volatiles Control, Models 383 and 384	Bio-Rad	JJY	Class I	1998-12-14
K984193	Dimensions Rxl Myoglobin (Myo) Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1998-12-14
K984093	Stratus (R) Cs Cardiac Troponin I (Trop) Testpak	Siemens Healthcare Diagnostics Inc.	MMI	Class II	1998-12-14
K984065	Stratus (R) Cs Myoglobin (Myo) Testpak	Siemens Healthcare Diagnostics Inc.	DDR	Class II	1998-12-14
K983803	The Aptus (Automated) Application of the Cmv Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the	Zeus Scientific LLC	LFZ	Class II	1998-12-14
K983489	Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or Le)	Ansell Perry	KGO	Class I	1998-12-14
K983340	Immage Immunochemistry System Ferritin (Fer)reagent, Immage Immunochemistry System Ferritin Calibrator	Siemens Healthcare Diagnostics Inc.	DBF	Class II	1998-12-14
K983309	Sensititre 19 - 24 Hour Susceptibility Plates with Levofloxacin	Accumed Intl., Inc.	LTT	Class II	1998-12-14
K983199	Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model	Fibra Sonics, Inc.	LFL	Unclassified	1998-12-14
K982694	Medline Medcrest Surgical Gowns and Surgical Drapes	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	1998-12-14
K982612	Esp7 Venous Image	Ironmaster, Inc.	KZA	Class I	1998-12-14
K982311	Bartels Cinakit Cmv Antigenemia	Intracel Corp.	GQH	Class II	1998-12-14
K981942	Latex Powder Free Examination Gloves	Maika Rubber Products Sdn Bhd	LYY	Class I	1998-12-14
K981643	Rtm Dvt Prosoft Cuff Model Number Ps100	R.T. Medical Services, Inc.	JOW	Class II	1998-12-14
K980845	Ms-900S, Ms-900Spm & Ms-900Sfm	Mars Medical Products	DXN	Class II	1998-12-14
K984299	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	JFP	Class II	1998-12-11
K984278	Magnetic Resonance Diagnostic Device, Airis II	FUJIFILM Healthcare Americas Corporation	MOS	Class II	1998-12-11
K984272	Magnetic Resonance Diagnostic Device, Model Mrp-5000	FUJIFILM Healthcare Americas Corporation	MOS	Class II	1998-12-11
K984196	Modification to Prowess Pro-Sim	Ssgi Prowess Systems	MUJ	Class II	1998-12-11
K984111	Fv-RF	Philips North America LLC	KPR	Class II	1998-12-11
K983821	Philips Inturis Cardio Image Viewing Package	Philips North America LLC	LLZ	Class II	1998-12-11
K983792	Seare Biomedical Silicone Tissue Expander	Seare Biomedical Corp.	LCJ	Unclassified	1998-12-11
K983765	Injection Needle Probe/device-Tunis	Ximed/Prosure/Injectx	FBK	Class II	1998-12-11
K983730	Omni Flex Nitrile Examination Glove, Powder-Free, Blue	Omnigrace, Ltd.	LZA	Class I	1998-12-11
K983729	Powder-Free Nitrile Patient Examination Glove	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	1998-12-11
K983718	Meropenem Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-12-11
K983703	Modification to Abuscreen Online for Methadone	Roche Diagnostic Systems, Inc.	DJR	Class II	1998-12-11
K983701	Modification to Abuscreen Online for Cannabinoids	Roche Diagnostic Systems, Inc.	LDJ	Class II	1998-12-11
K983700	Modification to Abuscreen Online for Propoxyphene	Roche Diagnostic Systems, Inc.	JXN	Class II	1998-12-11
K983699	Modification to Abuscreen Online for Amphetamines	Roche Diagnostic Systems, Inc.	DKZ	Class II	1998-12-11
K983697	Modification to Abuscreen Online Cocaine Metabolite	Roche Diagnostic Systems, Inc.	DIO	Class II	1998-12-11
K983649	Max-Act	Array Medical, Inc.	JBP	Class II	1998-12-11
K983630	Seare Biomedical Silicone Rods	Seare Biomedical Corp.	MIB	Class II	1998-12-11
K983628	Xenon Light Source Auto Lip 5123, Model 2123.011	Richard Wolf Medical Instruments Corp.	GCT	Class II	1998-12-11
K983599	Safetex Chlamydia Trachomatis Specimen Collection Kit	Andwin Scientific	HHT	Class II	1998-12-11
K983526	Vertical Lift	Barnes,Richardson & Colburn	ING	Class II	1998-12-11
K983463	Surecaut Diamond Laser Knife	Clinicon Corp.	GEX	Class II	1998-12-11
K983382	Osteonics Ha Generation II Acetabular Component System	Osteonics Corp.	MEH	Class II	1998-12-11