Cleared Special

Blood Volume Analyzer (200) (K261099) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261099 · Daxor Corporation · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
77d
Days
Class 2
Risk

K261099 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 June 18, 2026 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5950 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Daxor Corporation devices

Submission Details

510(k) Number K261099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2026
Decision Date June 18, 2026
Days to Decision 77 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.