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FDA 510(k)

OxyMinder Pro (10310)

K-Number: K251245 · 2025-08-11

ApplicantBio-Med Device, Inc.
Decision Date2025-08-11
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OxyMinder Pro (10310) is a medical device manufactured by Bio-Med Device, Inc.. It received FDA 510(k) clearance on 2025-08-11 under approval number K251245. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxyMinder Pro (10310)?

OxyMinder Pro (10310) is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Bio-Med Device, Inc.. The 510(k) number is K251245.

When was OxyMinder Pro (10310) approved by the FDA?

OxyMinder Pro (10310) received FDA 510(k) clearance on 2025-08-11, under approval number K251245.

What company makes OxyMinder Pro (10310)?

OxyMinder Pro (10310) is manufactured by Bio-Med Device, Inc..

What is the FDA product code for OxyMinder Pro (10310)?

The FDA product code for OxyMinder Pro (10310) is CCL.

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Official Source

View on FDA Database →

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

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