Cleared Traditional

K192731 - ZIDA Wearable Neuromodulation System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192731 · Exodus Innovations · Gastroenterology & Urology device
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Mar 2021
Decision
539d
Days
Class 2
Risk

K192731 is an FDA 510(k) clearance for the ZIDA Wearable Neuromodulation System. Classified as Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (product code NAM), Class II - Special Controls.

Submitted by Exodus Innovations (Sufa, IL). The FDA issued a Cleared decision on March 19, 2021 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5310 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Exodus Innovations devices

Submission Details

510(k) Number K192731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date March 19, 2021
Days to Decision 539 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
409d slower than avg
Panel avg: 130d · This submission: 539d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAM Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5310
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 Consultant

Msquared Associates, Inc.
Cherita James

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.