# K990808: PBN Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Nov 26, 1999 after 260 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K961904 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961904: AQ Hydrophilic Dilators, Cook Urological, Inc. (1996) Summary page 1.

## Most influential descendants
- K183036: Dilator Sets (2018), 1 descendant of its own
- K210734: Endovascular Dilator and Sets (2021), 0 descendants of its own

## Indications for use
The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.

Source page: https://510kreport.com/device/K990808
Methodology: https://510kreport.com/methodology