Cleared Traditional

K941965 - EZ-RANGE

K941965 is an FDA 510(k) clearance for EZ-RANGE, manufactured by Hematronix, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K941965

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.

JPK Device Classification - Class 2, Special Controls

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 167
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