Cleared Traditional

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

K260756 is an FDA 510(k) clearance for TraumaGuard Intra-Abdominal Pressure-Se..., manufactured by Sentinel Medical Technologies,. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K260756 · Sentinel Medical Technologies, · Gastroenterology & Urology device
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Sep 2026
Decision
179d
Days
Class 2
Risk

K260756 is an FDA 510(k) clearance for the TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221). Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Sentinel Medical Technologies, (Jacksonville, US). The FDA issued a Cleared decision on September 4, 2026 after a review of 179 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentinel Medical Technologies, devices

FDA 510(k) Submission Details - K260756

510(k) Number K260756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2026
Decision Date September 04, 2026
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 131d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 113
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K260756.
Rusch Latex Gold Foley Catheter
K262056 · Teleflex Medical Sdn. Bhd. · Aug 2026
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Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · Guangdong Ecan Medical Co., Ltd. · Jun 2025
InnoCare Specialty Foley Catheter
K241424 · Innocare Urologics, LLC · Sep 2024
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024