Data / Medical devices / Taiwan / Hsiner Co., Ltd.

Hsiner Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 7 510(k) clearances

Name: Hsiner Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hsiner Co., Ltd. is registered with the FDA (registration 3031369651) in Taichung City, Taiwan. It lists 26 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3031369651
Address: No. 251, Sec.1,Houke Rd., Houli Dist., Taichung City, Taiwan, 421
Owner or operator: HSINER CO., LTD. (9053474)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: October 22, 2002
Registered through: 2026
Brand names listed: & GAS LINE, ACCESSORIES;, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece, Aerosol Mask Adult, Aerosol Mask Child, Aerosol Mouthpiece and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Contract manufacturer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Contract manufacturer	accessdata.fda.gov
Strap, Head, Gas Mask	BTK	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tent, Oxygen	BYL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Contract manufacturer, Exporter to the US, Manufacturer	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
March 12, 2026	K251888	VPAP Pediatric Face Mask	CBK	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
July 24, 2009	K091185	70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER	CAH	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
August 22, 2008	K082009	HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS	CAF	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
April 25, 2007	K070948	HSINER NEBULIZER BOTTLE	CAF	Substantially Equivalent	Hsiner	accessdata.fda.gov
February 23, 2007	K063268	CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235	BZD	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
March 22, 2006	K053466	HSINER RESUSCITATOR	BTM	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov
December 21, 2005	K052811	HSINER JET NEBULIZER, MODEL HS-31100	CAF	Substantially Equivalent	Hsiner Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 12, 2026. 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.