Data / Medical devices / United States / Forsure Medical Products LLC.

Forsure Medical Products LLC.: FDA-registered device maker in Doral, FL, United States, 11 510(k) clearances

Name: Forsure Medical Products LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Forsure Medical Products LLC. is registered with the FDA (registration 3005609751) in Doral, FL, United States. It lists 22 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 4, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005609751
Address: 1303 Nw 78th Ave, Doral, FL, United States, 33126
Owner or operator: Forsure Medical Products LLC. (9100820)
Roles: Repackager or relabeler
First device listed: May 7, 2020
Registered through: 2026
Brand names listed: Forsure Aerosol Mask, Forsure Disposable Underpad, Forsure Endobroncial Tubes, Forsure Endotracheal Tube, Forsure Endotracheal Tube with Evacuation Lumen, Forsure Hypodermic Needle, Forsure IV Catheter, Forsure IV Sets and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Repackager or relabeler	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Repackager or relabeler	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-Sterile	NNX	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Repackager or relabeler	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Stapler, Skin	QQS	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Repackager or relabeler	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 4, 2022	K222124	Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
December 11, 2019	K182739	Endotracheal Tube with Evacuation Lumen	BTR	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
May 11, 2018	K170663	Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer	BTM	Substantially Equivalent	Foremount Enterprise Co., Ltd.	accessdata.fda.gov
October 11, 2017	K162340	Stomach Tube	KNT	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
March 11, 2010	K092886	WELL LEAD ENDOBRONCHIAL TUBES	CBI	Substantially Equivalent	Well Lead Instruments	accessdata.fda.gov
August 7, 2009	K083429	I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT	FOZ	Substantially Equivalent	Weihai Jierui Medical Products Co., Ltd.	accessdata.fda.gov
June 11, 2009	K083687	BAIXIN INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Anhui Kangda Medical Products Co., Ltd.	accessdata.fda.gov
October 8, 2008	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
July 10, 2008	K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
February 18, 2005	K042683	WELL LEAD ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
February 17, 2005	K042684	WELL LEAD TRACHEOSTOMY TUBE	BTO	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov

Compare with other makers

Updated November 4, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.