# K093718: Zutron Medical Endoscope Leak Tester Model Zutr-10003

- Pathway: 510(k) (Traditional)
- Applicant: Zutron Medical, LLC
- Decided: Feb 22, 2010 after 82 days
- Product code: FCY (Bulb, Inflation, For Endoscope)
- Device class: 1
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fujinon Leak Tester: named in the summary without a submission number
- (no number) SRI Leak Tester: named in the summary without a submission number
- (no number) Telemed Systems: named in the summary without a submission number

## Most influential descendants
- K123704: Automated Endoscope Leak Tester (2013), 1 descendant of its own
- K212201: PENTAX Medical Auto Leakage Tester SHA-P6 (2021), 0 descendants of its own

## Indications for use
The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.

Source page: https://510kreport.com/device/K093718
Methodology: https://510kreport.com/methodology