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Exin Medical Technology Company, LLC: FDA-registered device maker in Katy, TX, United States, 3 510(k) clearances

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

Exin Medical Technology Company, LLC is registered with the FDA (registration 3015191173) in Katy, TX, United States. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 11, 2018. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3015191173
Address: 2106 Scarlet Thistle Court, Katy, TX, United States, 77494
Owner or operator: Exin Medical Technology Company, LLC (10059125)
Roles: Repackager or relabeler
First device listed: July 21, 2022
Registered through: 2026
Brand names listed: Aerosol mask, Airway, Anesthesia breathing circuit, Anesthesia mask/ Cushion mask/ Silicone mask, CPR face shield, HMEF, Humidifier, Mouth opener 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
Bag, Reservoir	BTC	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Repackager or relabeler	accessdata.fda.gov
Clip, Nose	BXJ	1	Repackager or relabeler	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Repackager or relabeler	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Repackager or relabeler	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Repackager or relabeler	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Repackager or relabeler	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	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
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Repackager or relabeler	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	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
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
March 18, 2005	K042727	POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A	CBP	Substantially Equivalent	Foremount Ent. Co., Ltd.	accessdata.fda.gov
September 20, 2004	K032878	KUNG SHIN, HMEF SK203	CAH	Substantially Equivalent	Kung Shin Plastics Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 11, 2018. 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.