510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K210570Substantially Equivalent

TraumaGuard Intra-abdominal Pressure Sensing System

Sentinel Medical Technologies, LLC, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210570 is the FDA 510(k) clearance record for TraumaGuard Intra-abdominal Pressure Sensing System, cleared for Sentinel Medical Technologies, LLC on under FDA product code PHU (Intra-Abdominal Pressure Monitoring Device). FDA's definition for product code PHU reads: "Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure". FDA records list 2 510(k) clearances for Sentinel Medical Technologies, LLC, from to . As of , FDA records show no recalls naming K210570.

Clearance record

Decision date
Received
(245 days to decision)
Product code
PHU Intra-Abdominal Pressure Monitoring Device
Device class
Unclassified
Review panel
Unknown
Applicant
Sentinel Medical Technologies, LLC 50 N Laura St., Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHU

Trailing 12 months

FDA records hold no clearances under product code PHU in the trailing twelve months.

FDA records show no clearances under product code PHU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260