Class Class II
iSage Rx (K242066)
Description
iSage Rx by Amalgam Rx, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242066
Clearance Date2024-08-21
Clearance TypeTraditional
Product CodeNDC
Regulation Number868.1890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242066
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. iSage Rx (K242066) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | Isag Rx, Inc. | 2017 |
Trace the full predicate network for K242066
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.