Class Class II
Duet External Drainage and Monitoring System (EDMS) (K242034)
Description
Duet External Drainage and Monitoring System (EDMS) by Medtronic Neurosurgery, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242034
Clearance Date2024-10-24
Clearance TypeSpecial
Product CodePCB
Regulation Number882.5560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242034
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. Duet External Drainage and Monitoring System (EDMS) (K242034) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole... | Medtronic, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2025 |
Trace the full predicate network for K242034
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.