# K261099: Blood Volume Analyzer (200)

- Pathway: 510(k) (Special)
- Applicant: Daxor Corporation
- Decided: Jun 18, 2026 after 77 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
Longest line of descent: 2 generations back to K964406 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251087: Blood Volume Analyzer (200), Daxor Corporation (2025) Summary page 5.

## Indications for use
The Daxor BVA-200® is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit. The Daxor BVA-200 is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin. The Daxor BVA-200 provides a Quantitative Assessment of total blood and plasma volumes using an automated system. Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results. For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians. Rx use only.

Source page: https://510kreport.com/device/K261099
Methodology: https://510kreport.com/methodology