# K062342: Truepulse Disposable Invasive Blood Pressure Monitoring Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sentra Medical Devices, LLC
- Decided: Sep 25, 2006 after 45 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832907 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832907: Invasive Monitoring Kits, American Pharmaseal Div. Ahsc (1984)

## Indications for use
Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.

Source page: https://510kreport.com/device/K062342
Methodology: https://510kreport.com/methodology