Class Class II
High Pressure Tubing (K244038)
Description
High Pressure Tubing by Shandong Int Medical Instruments Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244038
Clearance Date2025-09-05
Clearance TypeTraditional
Product CodeDXT
Regulation Number870.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244038
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. High Pressure Tubing (K244038) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., ... | 2026 |
Trace the full predicate network for K244038
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.