Cleared Traditional

K972470 - CRIT-LINE MONITOR (CLMIII)

K972470 is an FDA 510(k) clearance for CRIT-LINE MONITOR (CLMIII), manufactured by In-Line Diagnostics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K972470 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
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Dec 1997
Decision
163d
Days
Class 2
Risk

K972470 is an FDA 510(k) clearance for the CRIT-LINE MONITOR (CLMIII). Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Great Neck, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 163 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

FDA 510(k) Submission Details - K972470

510(k) Number K972470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date December 11, 1997
Days to Decision 163 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
32d slower than avg
Panel avg: 131d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQS Device Classification - Class 2, Special Controls

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

All 16
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K972470.
HP M2376A DEVICE LINK SYSTEM
K984194 · Hewlett-Packard Co. · Apr 1999
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K982412 · In-Line Diagnostics Corp. · Oct 1998
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · Transonic Systems, Inc. · Oct 1998
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · Transonic Systems, Inc. · Feb 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · Cobe Renal Care, Inc. · Feb 1997
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
K953875 · In-Line Diagnostics Corp. · Jul 1996