# K212201: PENTAX Medical Auto Leakage Tester SHA-P6

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Oct 1, 2021 after 79 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: 6 generations back to K931154 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123704: Automated Endoscope Leak Tester, Olympus Medical Systems Corp. (2013) Summary page 4.

## Indications for use
The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes.

Source page: https://510kreport.com/device/K212201
Methodology: https://510kreport.com/methodology