Class Class II
hygh-tec drainage (K221400)
Description
hygh-tec drainage by Creative Balloons GmbH, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221400
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeKNT
Regulation Number876.5980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221400
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. hygh-tec drainage (K221400) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025 |
Trace the full predicate network for K221400
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.