# K123704: Automated Endoscope Leak Tester

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Feb 4, 2013 after 63 days
- Product code: PCV (Endoscopic Leak Tester)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931154 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093718: Zutron Medical Endoscope Leak Tester Model Zutr-10003, Zutron Medical, LLC (2010) Summary page 2.
- K051886: Olympus Choledochoscope, Model XCHF-BP160F, Olympus Medical Systems Corporation (2005) Summary page 2.

## Most influential descendants
- K212201: PENTAX Medical Auto Leakage Tester SHA-P6 (2021), 0 descendants of its own

## Indications for use
This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.

Source page: https://510kreport.com/device/K123704
Methodology: https://510kreport.com/methodology