Cleared Traditional

K162471 - Hach CM130 Chlorine Monitoring System (FDA 510(k) Clearance)

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

K162471 · Hach Company · Gastroenterology & Urology device
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Mar 2017
Decision
205d
Days
Class 2
Risk

K162471 is an FDA 510(k) clearance for the Hach CM130 Chlorine Monitoring System. Classified as Chlorine Meter (product code PSX), Class II - Special Controls.

Submitted by Hach Company (Ames, US). The FDA issued a Cleared decision on March 30, 2017 after a review of 205 days - an extended review cycle.

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. 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.

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Submission Details

510(k) Number K162471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date March 30, 2017
Days to Decision 205 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
75d slower than avg
Panel avg: 130d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSX Chlorine Meter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
Definition These Devices Are Intended To Measure Chlorine Levels In Water.
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.