Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (K212161)
Description
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories by Masimo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212161
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. Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (K212161) cites 3 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 |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Rad... | Masimo Corporation | 2020 |
Trace the full predicate network for K212161
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.