# K254074: TruPress

- Pathway: 510(k) (Traditional)
- Applicant: Procerus Enterprises
- Decided: Sep 10, 2026 after 266 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: 5 generations back to K831506 (1983). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101518: Compass Vascular Access; Compass Lumbar Puncture, Mirador Biomedical, Inc. (2010) Summary page 5.

## Indications for use
The Procerus TruPress is a single-use, sterile, disposable device intended for use on adult patients for direct measurement of arterial or venous pressure at the site where a compatible introducer needle is inserted while attached to the TruPress device.

Source page: https://510kreport.com/device/K254074
Methodology: https://510kreport.com/methodology