Class Class II
Inomax DSIR (K211153)
Description
Inomax DSIR by Mallinckrodt Manufacturing, LLC, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK211153
Clearance Date2023-04-20
Clearance TypeTraditional
Product CodeMRN
Regulation Number868.5165
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K211153
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. Inomax DSIR (K211153) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020 |
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics/Ikaria | 2013 |
Trace the full predicate network for K211153
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.