Class Class II
MONARCH™ Platform (MON-000008) (K243219)
Description
MONARCH™ Platform (MON-000008) by Auris Health, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243219
Clearance Date2025-01-23
Clearance TypeTraditional
Product CodeEOQ
Regulation Number874.4680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243219
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. MONARCH™ Platform (MON-000008) (K243219) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211493 | Monarch Platform | Auris Health, Inc. | 2021 |
Trace the full predicate network for K243219
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.