Cleared Traditional

K982412 - MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

K982412 is an FDA 510(k) clearance for MODIFICATION OF CRIT-LINE MONITOR III (..., 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 88-day FDA review.

K982412 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
88d
Days
Class 2
Risk

K982412 is an FDA 510(k) clearance for the MODIFICATION OF 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. (Farmington, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all In-Line Diagnostics Corp. devices

FDA 510(k) Submission Details - K982412

510(k) Number K982412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date October 09, 1998
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 K982412.
HP M2376A DEVICE LINK SYSTEM
K993587 · Hewlett-Packard Co. · Jan 2000
CRIT-LINE MONITOR III (CLM III)
K992227 · In-Line Diagnostics Corp. · Jul 1999
HP M2376A DEVICE LINK SYSTEM
K984194 · Hewlett-Packard Co. · Apr 1999
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · Transonic Systems, Inc. · Oct 1998
CRIT-LINE MONITOR (CLMIII)
K972470 · In-Line Diagnostics Corp. · Dec 1997
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · Transonic Systems, Inc. · Feb 1997