Cleared Traditional

K001763 - CRIT-LINE MONITOR III (CLM III)

K001763 is the FDA 510(k) clearance for CRIT-LINE MONITOR III (CLM III) by In-Line Diagnostics Corp.. It is a Class 2 Gastroenterology & Urology device (product code MQS) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K001763 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
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Dec 2000
Decision
191d
Days
Class 2
Risk

K001763 is an FDA 510(k) clearance for the CRIT-LINE MONITOR III (CLM III). Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Kaysville, US). The FDA issued a Cleared decision on December 20, 2000 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 In-Line Diagnostics Corp. devices

Submission Details

510(k) Number K001763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date December 20, 2000
Days to Decision 191 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
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQS System, Hemodialysis, Access Recirculation Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Peers - MQS System, Hemodialysis, Access Recirculation Monitoring

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