Class Class II
EDEN ControlCath (K241410)
Description
EDEN ControlCath by Jmt Co., Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241410
Clearance Date2025-02-13
Clearance TypeTraditional
Product CodeBSO
Regulation Number868.5120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241410
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. EDEN ControlCath (K241410) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150789 | SPINAUT-E, SPINAUT-I | Imedicom Co., Ltd. | 2016 |
Trace the full predicate network for K241410
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.