TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

FDA 510(k) K260756 · Sentinel Medical Technologies,

Substantially Equivalent

510(k) numberK260756

Submission

Device name
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Applicant
Sentinel Medical Technologies,
Jacksonville, FL, US
Received
March 9, 2026
Decision date
September 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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K232469Rüsch Latex Gold Foley CatheterEZL · Traditional Teleflexmedical, Inc.08/01/2024SE
K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional Sentinel Medical Technologies, LLC04/17/2024SE
K233411Folysil Silicone CatheterEZL · Traditional Coloplast Corp.04/15/2024SE
K2330132-Way 100% Silicone Cleartract CatheterEZL · Traditional Silq Technologies Corporation01/23/2024SE
K212077Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional Teleflexmedical, Inc.07/27/2023SE
K231101Flume CatheterEZL · Special Flume Catheter Company, Ltd.06/29/2023SE

More from Flume Catheter Company, Ltd.

510(k)DeviceDecision
K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional 04/17/2024SE
K210570TraumaGuard Intra-abdominal Pressure Sensing SystemPHU · Traditional 10/29/2021SE

Questions and answers

When was TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) cleared by the FDA?

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) (K260756) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 179 days after the submission was received.

What is the product code of K260756?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.