510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964406Substantially Equivalent

Automated Multi-Point Blood Volume Analyzer

Daxor Corporation, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964406 is the FDA 510(k) clearance record for AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER, a class II device, cleared for Daxor Corporation on under FDA product code JWO (Device, Blood Volume Measuring). FDA records list one 510(k) clearance for Daxor Corporation. As of , FDA records show no recalls naming K964406.

Clearance record

Decision date
Received
(325 days to decision)
Product code
JWO Device, Blood Volume Measuring
Regulation
21 CFR 864.5950
Device class
Class II
Review panel
Hematology
Applicant
Daxor Corporation 350 Fifth Ave., Suite 7120, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code JWO

Trailing 12 months
1 clearance under product code JWO in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JWO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260