Cleared Traditional

K210570 - TraumaGuard Intra-abdominal Pressure Sensing System (FDA 510(k) Clearance)

K210570 · Sentinel Medical Technologies, LLC · General & Plastic Surgery device
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Oct 2021
Decision
245d
Days
-
Risk

K210570 is an FDA 510(k) clearance for the TraumaGuard Intra-abdominal Pressure Sensing System. Classified as Intra-abdominal Pressure Monitoring Device (product code PHU).

Submitted by Sentinel Medical Technologies, LLC (Jacksonville, US). The FDA issued a Cleared decision on October 29, 2021 after a review of 245 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K210570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2021
Decision Date October 29, 2021
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 114d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHU Intra-abdominal Pressure Monitoring Device
Device Class -
Definition Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure.

Regulatory Consultant

Tpl Consulting
Darci Diage

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.