Submission Details
| 510(k) Number | K251087 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 09, 2025 |
| Decision Date | August 04, 2025 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
Blood Volume Analyzer (200)
Aug 2025
Decision
117d
Days
Class 2
Risk
About This 510(k) Submission
K251087 is an FDA 510(k) clearance for the Blood Volume Analyzer (200), a Device, Blood Volume Measuring (Class II — Special Controls, product code JWO), submitted by Daxor Corporation (Oak Ridge, US). The FDA issued a Cleared decision on August 4, 2025, 117 days after receiving the submission on April 9, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5950.
Device Classification
| Product Code | JWO — Device, Blood Volume Measuring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5950 |
Manufacturer
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