# K081940: Avalon Elite Vascular Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Avalon Laboratories, LLC
- Decided: Nov 18, 2008 after 133 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: 3 generations back to K891022 (1989). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070749: Estech Percutaneous Insertion Dilator Kit, Coombs Medical Device Consulting (2007) Summary page 1.

## Most influential descendants
- K162181: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (2017), 1 descendant of its own
- K253616: ProtekDilate Vascular Access Kit (2025), 0 descendants of its own
- K182914: MC3 Vascular Access Kit 21030 (2018), 0 descendants of its own
- K120349: Sonixgps Vascular Access Needle Kit (2012), 0 descendants of its own

## Recalls of this device
- Feb 20, 2020 · Class II · Z-1603-2020: A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle 

## Indications for use
intended for single use by trained physician to assist in vessel cannulation.

Source page: https://510kreport.com/device/K081940
Methodology: https://510kreport.com/methodology