Device, Blood Volume Measuring
Device, Blood Volume Measuring is a hematological diagnostic device used to quantify total blood volume, plasma volume, or red cell mass in a patient, typically employing radiolabeled tracers or indicator dilution methods, with applications in evaluating conditions such as anemia, polycythemia, and hemodynamic disorders. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JWO, regulated under 21 CFR 864.5950, and falls within the Hematology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JWO
- Device Class
- FDA class 2
- Regulation Number
- 864.5950
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261099 | Blood Volume Analyzer (200) | Jun 18, 2026 | Substantially Equivalent | Daxor Corporation |
| K251087 | Blood Volume Analyzer (200) | Aug 04, 2025 | Substantially Equivalent | Daxor Corporation |
| K964406 | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | Sep 25, 1997 | Substantially Equivalent | Daxor Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.