Cleared Traditional

K924167 - CRIT-LINE (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924167 · Noninvasive Medical Technology Corp. · Hematology device
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May 1993
Decision
261d
Days
Class 2
Risk

K924167 is an FDA 510(k) clearance for the CRIT-LINE. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Noninvasive Medical Technology Corp. (Ogden, US). The FDA issued a Cleared decision on May 7, 1993 after a review of 261 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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.

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Submission Details

510(k) Number K924167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date May 07, 1993
Days to Decision 261 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 113d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPI Device, Hematocrit Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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.