# K210570: TraumaGuard Intra-abdominal Pressure Sensing System

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Medical Technologies, LLC
- Decided: Oct 29, 2021 after 245 days
- Product code: PHU (Intra-Abdominal Pressure Monitoring Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003289 (2001). 4 ancestors in all.
2 later devices descend 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)
- K153655: Accuryn Monitoring System, Potrero Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K240057: TraumaGuard Intra-abdominal Pressure Sensing System (2024), 1 descendant of its own
- 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/K210570
Methodology: https://510kreport.com/methodology