Cleared Special

K992227 - CRIT-LINE MONITOR III (CLM III)

K992227 is an FDA 510(k) clearance for CRIT-LINE MONITOR III (CLM III), manufactured by In-Line Diagnostics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Special 510(k) pathway after a 28-day FDA review.

K992227 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
28d
Days
Class 2
Risk

K992227 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. (Farmington, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all In-Line Diagnostics Corp. devices

FDA 510(k) Submission Details - K992227

510(k) Number K992227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date July 30, 1999
Days to Decision 28 days
Submission Type Special
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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K992227.
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
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TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · Transonic Systems, Inc. · Aug 2002
HP M2376A DEVICE LINK SYSTEM
K993587 · Hewlett-Packard Co. · Jan 2000
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