Class Class II
embecta Insulin Delivery System (K234027)
Description
embecta Insulin Delivery System by Embecta Medical I, LLC, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234027
Clearance Date2024-08-30
Clearance TypeTraditional
Product CodeQFG
Regulation Number880.5730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234027
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. embecta Insulin Delivery System (K234027) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191679 | Omnipod DASH Insulin Management System with interoperable t... | Insulet Corporation | 2019 |
Trace the full predicate network for K234027
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.