# K050502: Single Use Balloon Dilator Maxpasstm

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jul 8, 2005 after 130 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 K920361 (1992). 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)
- K920361: Bard Biliary Balloon Dilators, C.R. Bard, Inc. (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K013338: Microvasive Rapid Exchange Biliary Balloon Dilation Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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

## Indications for use
Single use balloon dilator Maxpass to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major papilla during endoscopic applications.

Source page: https://510kreport.com/device/K050502
Methodology: https://510kreport.com/methodology