# K964406: Automated Multi-Point Blood Volume Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Daxor Corporation
- Decided: Sep 25, 1997 after 325 days
- Product code: JWO (Device, Blood Volume Measuring)
- Device class: 2
- Regulation: 21 CFR 864.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K251087: Blood Volume Analyzer (200) (2025), 1 descendant of its own
- K261099: Blood Volume Analyzer (200) (2026), 0 descendants of its own

## Indications for use
The Daxor BVA-100 is a software package designed to calculate human blood volume, using the mcthod of tracer dilution, utilizing tagged serum albumin (a commonly uscd tag is I-131, resulting in “I-HSA™”). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the patient expected (or idcal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results. The patient blood samples and the calibration standards arc measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

Source page: https://510kreport.com/device/K964406
Methodology: https://510kreport.com/methodology