Cleared Traditional

K964406 - AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER

K964406 is an FDA 510(k) clearance for AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER, manufactured by Daxor Corporation. The device is a Class 2 Hematology device with product code JWO cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K964406 · Daxor Corporation · Hematology device
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Sep 1997
Decision
325d
Days
Class 2
Risk

K964406 is an FDA 510(k) clearance for the AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER. Classified as Device, Blood Volume Measuring (product code JWO), Class II - Special Controls.

Submitted by Daxor Corporation (New York, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5950 - 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 Daxor Corporation devices

FDA 510(k) Submission Details - K964406

510(k) Number K964406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date September 25, 1997
Days to Decision 325 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
212d slower than avg
Panel avg: 113d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWO Device Classification - Class 2, Special Controls

Product Code JWO Device, Blood Volume Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5950
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.