Cleared Traditional

K193169 - Nelson Sentinel Series Basic Chlorine Sentinel (FDA 510(k) Clearance)

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

K193169 · Nelson Environmental Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
349d
Days
Class 2
Risk

K193169 is an FDA 510(k) clearance for the Nelson Sentinel Series Basic Chlorine Sentinel. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Nelson Environmental Technologies, Inc. (Mcallen, US). The FDA issued a Cleared decision on October 29, 2020 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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. Elevated predicate reliance profile. 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 Nelson Environmental Technologies, Inc. devices

Submission Details

510(k) Number K193169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2019
Decision Date October 29, 2020
Days to Decision 349 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 130d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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.