# K920361: Bard Biliary Balloon Dilators

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 24, 1992 after 302 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
No predicates in its family tree.
4 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050502: Single Use Balloon Dilator Maxpasstm (2005), 3 descendants of its own
- K150142: Single Use Balloon Dilator V (with Knife) (2015), 1 descendant of its own
- K193039: Single Use Balloon Dilator V (with knife) (2019), 0 descendants of its own
- K143303: Single Use Biliary Balloon Dilator (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K920361
Methodology: https://510kreport.com/methodology