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 2389 of 3531

510(k) clearances, page 2389 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920123	Spectacle Frames	Po-Le Optiks	HQZ	Class I	1992-03-06
K915861	Medilens-Cs Corneal Shield	Chiron Ophthalmics	MOE	Class I	1992-03-06
K915511	Mirage Complete Kit and Mirage Abc Kit	Mirage Dental Systems	KLE	Class II	1992-03-06
K915506	Laparoscopic Cholangiogram Catheter Kit	United States Endoscopy Group, Inc.	GCA	Class II	1992-03-06
K915504	Gambro Lundia Alpha Hemodialyzers	C.G.H. Medical, Inc.	FJG	Class II	1992-03-06
K915499	Flo-Gard 8000 Half-Set	Baxter Healthcare Corporation	FRN	Class II	1992-03-06
K915497	Conbio Medlite Q-Switched Nd:yag Laser System	Continuum Biomedical, Inc.	GEX	Class II	1992-03-06
K914924	Chemo Priming Pin(tm)	Block Medical, Inc.	FPA	Class II	1992-03-06
K914834	Vortech 3M Network Printing	Vortech Data, Inc.	LMC	Class II	1992-03-06
K914375	Non-Weighted Polyurethane Enteral Feeding Tube	Sherwood Medical Co.	KNT	Class II	1992-03-06
K913997	Saecg Cardiograph Model M1754a	Hewlett-Packard Co.	KNT	Class II	1992-03-06
K913908	Omnitron Gyn Applicator System	Omnitron Intl., Inc.	JAQ	Class II	1992-03-06
K913896	Jain Blood Shield	Jain Surgical Equipment, Inc.	JOL	Class II	1992-03-06
K913876	Endotracheal Suctiontube	Willowtech	JOL	Class II	1992-03-06
K913401	Suction Control Footswitch with Speed Control	Smith & Nephew Dyonics, Inc.	HRX	Class II	1992-03-06
K912941	Tampon, Untreated	Hygieia Healthcare, Ltd.	HEB	Class II	1992-03-06
K920159	Mobile Mrp-7000	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1992-03-05
K914209	Model 310Ge-64: Whole Volume Neck Coil	Medical Advances, Inc.	LNH	Class II	1992-03-05
K912046	Single Use Lee Electrode	Aspen Labs	HGI	Class II	1992-03-05
K911735	Artech Ardent IV - Type Clylinder Implant	Artech Corp.	DZE	Class II	1992-03-05
K920336	Miles Aspartate Aminotransferase Sera-Pak Method	Kulzer GmbH	CIT	Class II	1992-03-04
K920299	Medix Biotech Hghenzyme Immunoassay Test Kit	Medix Biotech, Inc.	CFL	Class I	1992-03-04
K920208	Urine a Calibrator	Diagnostic Reagents, Inc.	DKB	Class II	1992-03-04
K920064	Opti-Lens Contact Lens Case	Ryder Intl. Corp.	LRX	Class II	1992-03-04
K915893	Rubella Igg Elisa Test	Gull Laboratories, Inc.	LFX	Class II	1992-03-04
K915891	Toxo Igg Elisa Test (Modified)	Gull Laboratories, Inc.	LGD	Class II	1992-03-04
K915884	Vidas Chlamydia Assay, Modification	Vitek Systems, Inc.	LJC	Class I	1992-03-04
K915795	Perfecta Pda Total Hip System	Orthomet, Inc.	JDI	Class II	1992-03-04
K915462	Fibrinogen Control	Sigma Diagnostics, Inc.	GIL	Class II	1992-03-04
K915426	Medical Sunlamp for Phototherapy	American Sunlight, Inc.	FTC	Class II	1992-03-04
K915409	Intraosseous Access Needle	Cook Inc.	FMI	Class II	1992-03-04
K915193	Sarns Retrograde Cannula	3M Health Care, Sarns	DWF	Class II	1992-03-04
K915185	Gap Igg H.pylori Modified	Biomerica	LYR	Class I	1992-03-04
K915137	Kallestad Rotavirus Microplate	Bio-Rad Laboratories Inc.	LIQ	Class I	1992-03-04
K914949	Coagulation Arpr,cat.no.5185	Helena Laboratories, Corp.	GGN	Class II	1992-03-04
K914902	Clostridium Difficile Tox-a-Test	Techlab, Inc.	LLH	Class I	1992-03-04
K914889	Gemscom Series 3000	General Devices	DRG	Class II	1992-03-04
K914789	Elisa Cmv Igm	Sclavo, Inc.	LKQ	Class II	1992-03-04
K914315	Optical Catheter Introducer Sets, Modification	Medical Dynamics, Inc.	KGX	Class I	1992-03-04
K914278	Daig Electrophysiology Catheter W/infusion Lumen	Daig Corp.	DRF	Class II	1992-03-04
K914241	Pioneer Pro-Pump Dual Control	Pioneer Medical, Inc.	HHK	Class II	1992-03-04
K914220	Pioneer Pro-Pump	Pioneer Medical, Inc.	HHK	Class II	1992-03-04
K913931	Pancretec Provider(r) Model 5500 Infus Pump, Modif	Abbott Medical	FRN	Class II	1992-03-04
K913505	Enzygnost Toxoplasmosis/igm	Behring Diagnostics, Inc.	LGD	Class II	1992-03-04
K913258	Disposable Introsseous Infusion Needles	Cook Inc.	FMI	Class II	1992-03-04
K912580	First Choice	Polymer Technology Corp.	CGA	Class II	1992-03-04
K911645	Ngm Nibp Module	Datex Division Instrumentarium Corp.	DXN	Class II	1992-03-04
K911644	Ngm Frame	Datex Division Instrumentarium Corp.	CBQ	Class II	1992-03-04
K915436	Bladderscan Bvi 2500	Diagnostic Ultrasound Corp.	IYO	Class II	1992-03-03
K920583	Abbott Quickstart Amylase, #5Axx	Em Diagnostic Systems, Inc.	JFJ	Class II	1992-03-02