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 2343 of 3531

510(k) clearances, page 2343 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923432	German Mini Dynalock	Unitek Corp.	EJF	Class I	1992-10-30
K922760	Atraum Wound Dressing--Modification	Axiom Medical, Inc.	KMF	Class I	1992-10-30
K922479	Disposable Anesthesia Breathing Circuit, Modified	Intertech Resources, Inc.	BZO	Class I	1992-10-30
K922209	Nasograstric Tubbe Holder	Innovative Medical Design Corp.	KNT	Class II	1992-10-30
K922086	Bard Biopsy Forceps	C.R. Bard Inc	GCL	Class II	1992-10-30
K921936	Cordis Polypropylene Straight, T & Y Connector	Cordis US Corp.	JXG	Class II	1992-10-30
K921560	Vibrotactile Tester, Model No. Vtt-100	Topical Testing, Inc.	LLN	Class I	1992-10-30
K920219	Kinamed 26Mm Bioceran-Z Total Hip Femoral Ball	Kinamed Inc	LZO	Class II	1992-10-30
K915580	Belmont Model Pbp Intra-Aortic Balloon Pump	Belmont Medical Technologies	DSP	Class II	1992-10-30
K912921	Vsi 1000	Vitaltrends Technology, Inc.	FMT	Class II	1992-10-30
K924694	Lipase Hydrolysis/glycerot Kinase Enzyme, Triglyc	Olympus Corp.	CDT	Class I	1992-10-28
K923592	Patient Examination Gloves	Hindustan Latex, Ltd.	LYY	Class I	1992-10-28
K923539	American Dental Laser Single Use Contact 320 Handp	American Dental Laser, Inc.	GEX	Class II	1992-10-28
K923437	Boston Cleaner II	Polymer Technology Corp.	LPN	Class II	1992-10-28
K923341	Zeiss Visulas Argon Laser	Carl Zeiss, Inc.	GEX	Class II	1992-10-28
K922815	Royl-Derm Wound Hydrogel	Renaissance Medical, Inc.	MGQ	Unclassified	1992-10-28
K921990	Asi Uroplasty Laser Cystoscope	Advanced Surgical Intervention, Inc.	GEX	Class II	1992-10-28
K921839	Entrac Ureteral Balloon Dilation Catheters	American Medical Systems, Inc.	EZN	Class II	1992-10-28
K921822	Fray Bio-Punch	Fray Products Corp.	MDM	Class I	1992-10-28
K921804	Dextron Surgical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1992-10-28
K921690	Flexible Fiberoptic Sigmoidoscope System	Cogentix Medical, Inc.	FAM	Class II	1992-10-28
K921451	Evacuator, Gastro-Urology	Northgate Technologies Inc.	KQT	Class II	1992-10-28
K921243	Convertors Sterilization Wrap	Baxter Healthcare Corporation	FRG	Class II	1992-10-28
K921088	Evacuator, Gastro-Urology	Northgate Technologies Inc.	KQT	Class II	1992-10-28
K920601	Astra T2, Astra T4, Astra T6	Cardiac Pacemakers, Inc.	DXY	Class III	1992-10-28
K920551	120 Fr Optilume Prostate Balloon Dilator	American Medical Systems, Inc.	KOE	Class II	1992-10-28
K915848	Sensormedics Model 2450 Pulmonary Function Lab.	Sensor Medics Corp.	DZJ	Class II	1992-10-28
K915807	Eudermic Powder-Free Surgical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1992-10-28
K924665	Quickanchor	Mitek Surgical Products, Inc.	JDR	Class II	1992-10-27
K923926	Ips Ceramic Etching Gel	Ivoclar North America, Inc.	ELL	Class II	1992-10-27
K923851	Acqsim Simulator/localizer	Philips North America LLC	KPQ	Class II	1992-10-27
K923809	Puritan-Bennett Model 7200Ae Ventilator	Medtronic, Inc.	CBK	Class II	1992-10-27
K923399	Challenge II - Paste Adhesive	Ormco Corp.	DYH	Class II	1992-10-27
K923339	Tsrh L Connector -- Modification	Sofamor Danek Mfg., Inc.	KWP	Class II	1992-10-27
K923262	Dmg100 and 500 Isometric Strength Dynamometer	John Chatillon & Sons, Inc.	LBB	Class II	1992-10-27
K921854	Impla-Med Hex Screw Implants, 18 and 20 Mm	Impla-Med	DZE	Class II	1992-10-27
K921163	Regaltech Maxiscope	Regaltech Pty., Ltd.	HLI	Class II	1992-10-27
K920375	Disposable Intrauterine Pressure Transducer	Telos Medical Corp.	HFN	Class II	1992-10-27
K924766	Remel Ofloxacin 5Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1992-10-26
K924765	Remel Lomefloxacin 10 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1992-10-26
K924074	Stratus Vitamin B12 Fluorometric Enzyme-Linked	Baxter Diagnostics, Inc.	CDD	Class II	1992-10-26
K923921	Il Test Pt Fibrinogen Hs	Instrumentation Laboratory Co.	GIS	Class II	1992-10-26
K923802	Timesh Titanium Mini-Softplate/screw	Ti-Mesh, Inc.	JEY	Class II	1992-10-26
K923733	Cholesterol Test	Em Diagnostic Systems, Inc.	CHH	Class I	1992-10-26
K923641	Il Test Ast, Pn 35312	Instrumentation Laboratory Co.	CIT	Class II	1992-10-26
K923639	Diamond Coated Dental Inserts	Dentsply Intl.	ELC	Class II	1992-10-26
K923134	Cordis Steerable Guidewire	Cordis US Corp.	DQX	Class II	1992-10-26
K923122	Vitek Immunodiagnostic Assay System	Biomerieux Vitek, Inc.	LFY	Class II	1992-10-26
K923087	Il Test Apolipoprotein A1	Instrumentation Laboratory Co.	MSJ	Class I	1992-10-26
K923080	Il Test Apoliporotein B (Apo B)	Instrumentation Laboratory Co.	MSJ	Class I	1992-10-26