Cleared Traditional

K983551 - CRIT-SCAN II MONITOR

K983551 is the FDA 510(k) clearance for CRIT-SCAN II MONITOR by In-Line Diagnostics Corp.. It is a Class 2 Hematology device (product code GKF) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K983551 · In-Line Diagnostics Corp. · Hematology device
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May 1999
Decision
230d
Days
Class 2
Risk

K983551 is an FDA 510(k) clearance for the CRIT-SCAN II MONITOR. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Farmington, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 230 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all In-Line Diagnostics Corp. devices

Submission Details

510(k) Number K983551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date May 27, 1999
Days to Decision 230 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 113d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
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 Hematology devices follow this clearance model.

Regulatory Peers - GKF Instrument, Hematocrit, Automated

All 10
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K983551.
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STAT PROFILE M ANALYZER
K981427 · Nova Biomedical Corp. · May 1998
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825 · Fisher Scientific Co., LLC · Mar 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · Fisher Scientific Co., LLC · Jan 1992