510(k) · Cleared
ClearedBlood Volume Analyzer (200)
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 Jun 18, 2026 as substantially equivalent to K251087 (Daxor Corporation, 2025) after a 77-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 18, 2026
- Review
- 77 days
- Class
- Class II
- Product code
- JWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964406 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K251087 | Blood Volume Analyzer (200)Summary page 5…Blood Volume Analyzer Common or Usual Name: BVA-200 Regulatory Class: Class 2 Product Code: JWO III. PREDICATE DEVICE Daxor BVA-200, K251087 This predicate has not been subject to a design-related recall IV. DEVICE DESCRIPTION The Daxor BVA-200 is an… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 1 company; a new generation was cleared every 27.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JWO devicesJWO Device, Blood Volume Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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-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…
Read the full statement (224 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261099: Blood Volume Analyzer (200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261099
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026