Cleared Traditional

K251087 - Blood Volume Analyzer (200)

K251087 is an FDA 510(k) clearance for Blood Volume Analyzer (200), 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 117-day FDA review.

K251087 · Daxor Corporation · Hematology device
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Aug 2025
Decision
117d
Days
Class 2
Risk

K251087 is an FDA 510(k) clearance for the Blood Volume Analyzer (200). Classified as Device, Blood Volume Measuring (product code JWO), Class II - Special Controls.

Submitted by Daxor Corporation (Oak Ridge, US). The FDA issued a Cleared decision on August 4, 2025 after a review of 117 days - within the typical 510(k) review window.

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. 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 Daxor Corporation devices

FDA 510(k) Submission Details - K251087

510(k) Number K251087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2025
Decision Date August 04, 2025
Days to Decision 117 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 113d · This submission: 117d
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.