Data / Medical devices / Taiwan / Compal Electronics, Inc

Compal Electronics, Inc: FDA-registered device maker in Taoyuan City, Taiwan, 2 510(k) clearances

Name: Compal Electronics, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Compal Electronics, Inc is registered with the FDA (registration 3012428212) in Taoyuan City, Taiwan. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012428212
Address: 1,2,3,4,5F No.8-1 & 1,2F No.8, Nandong Rd., Pingzhen Dist., Taoyuan City, Taiwan, 32455
Owner or operator: COMPAL ELECTRONICS, INC (10059337)
Roles: Contract manufacturer, Manufacturer
First device listed: January 18, 2023
Registered through: 2026
Brand names listed: AblatePal, BreathePal Bilevel, C62, Dreem 3 System, Exo Iris (El2001), L154

Devices it lists

Device	Product code	Class	Role	Source
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer	accessdata.fda.gov
Ventilator, Continuous, Non-Life-Supporting	MNS	2	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 17, 2026	K252078	BreathePal Bilevel (GFM50-MD2201)	MNS	Substantially Equivalent	Compal Electronics, Inc.	accessdata.fda.gov
June 30, 2023	K223135	AblatePal Radiofrequency Ablation System	GEI	Substantially Equivalent	Compal Electronics, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 17, 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.