# K253616: ProtekDilate Vascular Access Kit

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Dec 19, 2025 after 31 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K891022 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162181: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set, Cardiacassist, Inc. (2017) Summary page 6.

## Indications for use
The ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.

Source page: https://510kreport.com/device/K253616
Methodology: https://510kreport.com/methodology