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) Official FDA 510(k) Summary (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.

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 17
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K992227.
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · Transonic Systems, Inc. · Aug 2002
CRIT-LINE MONITOR III (CLM III)
K001763 · In-Line Diagnostics Corp. · Dec 2000
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
K992227 · CRIT-LINE MONITOR III (CLM III)
Download PDF FDA Summary In-Line Diagnostics C…