# K240057: TraumaGuard Intra-abdominal Pressure Sensing System

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Medical Technologies, LLC
- Decided: Apr 17, 2024 after 100 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: 4 generations back to K003289 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210570: TraumaGuard Intra-abdominal Pressure Sensing System, Sentinel Medical Technologies, LLC (2021) Summary page 4.

## Most influential descendants
- K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) (2026), 0 descendants of its own

## Indications for use
TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). 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/K240057
Methodology: https://510kreport.com/methodology