# K162389: Medcomp Vessel Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp ( Medical Components)
- Decided: Jun 1, 2017 after 279 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: 1 generation back to K801113 (1980). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801113: Dilator, Vessel, for Perc. Catheter., Alva Medical, Inc. (1980) Summary page 4.

## Most influential descendants
- K183036: Dilator Sets (2018), 1 descendant of its own
- K210734: Endovascular Dilator and Sets (2021), 0 descendants of its own
- K192283: MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (2020), 0 descendants of its own

## Indications for use
The Medcomp Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

Source page: https://510kreport.com/device/K162389
Methodology: https://510kreport.com/methodology