510(k) · Cleared
ClearedAutomated Multi-Point Blood Volume Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daxor Corporation · JWO Device, Blood Volume Measuring
Cleared on Sep 25, 1997 after a 325-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Sep 25, 1997
- Review
- 325 days
- Class
- Class II
- Product code
- JWO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964406 | Automated Multi-Point Blood Volume Analyzer | Daxor Corporation | 1997 | — |
| +1 | K251087 | Blood Volume Analyzer (200) | Daxor Corporation | 2025 | — |
| +2 | K261099 | Blood Volume Analyzer (200) | Daxor Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWO device
- #1 K251087 Blood Volume Analyzer (200)score 12.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251087 | Blood Volume Analyzer (200) | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K251087 (Daxor Corporation, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JWO devicesJWO Device, Blood Volume Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWO
Too few JWO 510(k)s in any year since 2007 to give a median.
Recalls per year · JWO
No recall names JWO since 2007.
Adverse event reports per year · JWO
No MAUDE report names JWO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (111 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964406: Automated Multi-Point Blood Volume Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964406
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026