# K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Medical Technologies,
- Decided: Sep 4, 2026 after 179 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K003289 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240057: TraumaGuard Intra-abdominal Pressure Sensing System, Sentinel Medical Technologies, LLC (2024) Summary page 5.

## Indications for use
The TraumaGuard Intra-abdominal Pressure-Sensing System is intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension ("IAH") and abdominal compartment syndrome ("ACS").

Source page: https://510kreport.com/device/K260756
Methodology: https://510kreport.com/methodology