# K162181: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Jan 6, 2017 after 155 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891022 (1989). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081940: Avalon Elite Vascular Access Kit, Avalon Laboratories, LLC (2008) Summary page 4.

## Most influential descendants
- K253616: ProtekDilate Vascular Access Kit (2025), 0 descendants of its own

## Recalls of this device
- Mar 19, 2021 · Class II · Z-1486-2021: On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to th

## Indications for use
The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

Source page: https://510kreport.com/device/K162181
Methodology: https://510kreport.com/methodology