Data / Medical devices / United States / Braemar Manufacturing, LLC

Braemar Manufacturing, LLC: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances

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

Braemar Manufacturing, LLC is registered with the FDA (registration 3003584029) in San Diego, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 4, 2018. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003584029
Address: 3721 Valley Centre Drive, Suite 100, San Diego, CA, United States, 92130
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Specification developer
First device listed: November 12, 2003
Registered through: 2026
Brand names listed: 2-CH Patch, 40494E, Limb Clamp Electrode, 989803157481, DigiTrak XT Patient Cable, short, 989803157491, DigiTrak XT Patient Cable, Medium, 989803157501, DigiTrak XT Patient Cable, Long, BTP-1000A-Hybrid Patch, BTP-1000L-2-Lead Wire Adapter, BTP-1000M (Monitor) and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Specification developer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Specification developer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Specification developer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Specification developer	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
January 4, 2018	K171410	ePatch	DSH	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov
July 22, 2016	K153473	Braemar Telemetry Patch System	DSI	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 18, 2024	95837	Class I	Ongoing	Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.	Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.	accessdata.fda.gov

Compare with other makers

Updated December 23, 2024. 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.