Class Class II
OxyMinder Pro (10310) (K251245)
Description
OxyMinder Pro (10310) by Bio-Med Device, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251245
Clearance Date2025-08-11
Clearance TypeTraditional
Product CodeCCL
Regulation Number868.1720
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251245
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OxyMinder Pro (10310) (K251245) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022 |
Trace the full predicate network for K251245
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.