FDA 510(k)

Blood Volume Analyzer (200)

K-Number: K261099 · 2026-06-18

Decision Date2026-06-18

Product CodeJWO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Blood Volume Analyzer (200) is the device name listed in this FDA 510(k) record. The listed applicant is Daxor Corporation. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261099. The device is classified under product code JWO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blood Volume Analyzer (200)?

Blood Volume Analyzer (200) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Daxor Corporation. The 510(k) number is K261099.

When did Blood Volume Analyzer (200) receive FDA 510(k) clearance?

Blood Volume Analyzer (200) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261099.

Who is the listed applicant for Blood Volume Analyzer (200)?

The FDA 510(k) record lists Daxor Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Volume Analyzer (200)?

The FDA product code for Blood Volume Analyzer (200) is JWO.

Other records listing Daxor Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251087Blood Volume Analyzer (200)

Related Devices (Code: JWO)

K251087Blood Volume Analyzer (200)Daxor Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.