Cleared Traditional

K924167 - CRIT-LINE

K924167 is an FDA 510(k) clearance for CRIT-LINE, manufactured by Noninvasive Medical Technology Corp.. The device is a Class 2 Hematology device with product code JPI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

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.

View all Noninvasive Medical Technology Corp. devices

FDA 510(k) Submission Details - K924167

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.

JPI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JPI Device, Hematocrit Measuring

All 7
Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K924167.
i-STAT CHEM8+ cartridge with the i-STAT 1 System
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COMPUR* M1100 HEMATRCRIT SYSTEM
K831318 · Worthington Diagnostic Systems · Jun 1983
MICROHEMATOCRIT READER
K830578 · Fisher Scientific Co., LLC · Mar 1983
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558 · Fisher Scientific Co., LLC · Jan 1983