# K183036: Dilator Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 20, 2018 after 49 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961904 (1996). 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)
- K162389: Medcomp Vessel Dilator, Medcomp ( Medical Components) (2017) Summary page 4.
- K990808: PBN Dilators, Medical Device Technologies, Inc. (1999) Summary page 4.

## Most influential descendants
- K210734: Endovascular Dilator and Sets (2021), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class II · Z-1532-2024: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Mar 1, 2024 · Class II · Z-1530-2024: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Mar 1, 2024 · Class II · Z-1531-2024: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

## Indications for use
Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

Source page: https://510kreport.com/device/K183036
Methodology: https://510kreport.com/methodology