Class Class II
OrganProtex HTK Solution (K241239)
Description
OrganProtex HTK Solution by Bridge TO Life, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241239
Clearance Date2025-01-24
Clearance TypeTraditional
Product CodeKDL
Regulation Number876.5880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241239
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. OrganProtex HTK Solution (K241239) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020 |
Trace the full predicate network for K241239
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.