Cleared Traditional

K941965 - EZ-RANGE

K941965 is the FDA 510(k) clearance for EZ-RANGE by Hematronix, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K941965 · Hematronix, Inc. · Hematology device
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Apr 1995
Decision
368d
Days
Class 2
Risk

K941965 is an FDA 510(k) clearance for the EZ-RANGE. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematronix, Inc. (Benicia, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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. Elevated predicate reliance profile. 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 Hematronix, Inc. devices

Submission Details

510(k) Number K941965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date April 25, 1995
Days to Decision 368 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
255d slower than avg
Panel avg: 113d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K941965.
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · R&D Systems, Inc. · Oct 1995
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · Aalto Scientific, Ltd. · Sep 1995
SF-CHECK
K952245 · Streck Laboratories, Inc. · Sep 1995
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · R&D Systems, Inc. · Dec 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K943336 · R&D Systems, Inc. · Dec 1994
COULTER FLOW SET
K944751 · Coulter Corp. · Dec 1994