Class Class II
OxiWear (K233827)
Description
OxiWear by Oxiwear, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233827
Clearance Date2024-08-28
Clearance TypeTraditional
Product CodeDQA
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233827
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. OxiWear (K233827) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo... | Masimo Corporation | 2020 |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oxi... | Nonin Medical, Inc. | 2016 |
Trace the full predicate network for K233827
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.