FDA product code JWO: Device, Blood Volume Measuring
JWO is the FDA product code for device, blood volume measuring. It is a Class II device, regulated under 21 CFR 864.5950 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under JWO, 2 in the last five years. The average 510(k) review took 173 days (median 117); 97 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Blood Volume Measuring |
| Device class | Class II |
| Regulation | 21 CFR 864.5950 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JWO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 117 |
| 2026 | 1 | 77 |
Compare with all 510(k) review times · Search every JWO clearance
Top JWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Daxor Corporation | 3 | 2026-06-18 |
Most recent JWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261099 | Daxor Corporation | Blood Volume Analyzer (200) | 2026-06-18 | 77 |
| K251087 | Daxor Corporation | Blood Volume Analyzer (200) | 2025-08-04 | 117 |
| K964406 | Daxor Corporation | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | 1997-09-25 | 325 |
Recalls for JWO devices
openFDA lists no recalls for product code JWO.
Frequently asked questions
What is FDA product code JWO?
JWO is the FDA product code for device, blood volume measuring. It is a Class II device, regulated under 21 CFR 864.5950 and reviewed by the Hematology panel.
What device class is JWO?
Class II, regulation 21 CFR 864.5950. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWO?
Across 3 cleared submissions the average was 173 days from receipt to decision (median 117).
Which companies have the most JWO clearances?
Daxor Corporation (3).
Next steps
- Run an FDA pathway report with predicate devices for product code JWO
- Run a recall and safety report across every JWO manufacturer
- Watch product code JWO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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