Cleared Traditional

K211068 - PrevisEA Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K211068 · Entac Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
114d
Days
Class 2
Risk

K211068 is an FDA 510(k) clearance for the PrevisEA Device. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Entac Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 4, 2021 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1875 - 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 Entac Medical, Inc. devices

Submission Details

510(k) Number K211068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date August 04, 2021
Days to Decision 114 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
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Target Health, LLC
Adam Harris

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.

Clinical Evidence

ClinicalTrials.gov
NCT03505476 Completed Interventional

Optimizing the Previs Device for Prediction of Postoperative Ileus

203
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Ileus
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jennifer Hrabe
Sponsor Jennifer Hrabe
Started 2018-04-24 → Primary completion 2023-06-05
Primary outcome
Device Sensitivity for Predicting Ileus.
View full study on ClinicalTrials.gov

Regulatory Peers - DQD Stethoscope, Electronic

All 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K211068.
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