# K123446: TL-300 T-Line Non-Invasive Blood Pressure Monitoring System

- Pathway: 510(k) (Special)
- Applicant: United States Gtm Medical Devices, Inc.
- Decided: Dec 7, 2012 after 29 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K201302: LiveOne (2022), 0 descendants of its own

## Indications for use
This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.

Source page: https://510kreport.com/device/K123446
Methodology: https://510kreport.com/methodology