# K243075: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Nov 8, 2024 after 42 days
- Product code: ODC (Endoscope Channel Accessory)
- 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: 8 generations back to K944759 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes, STERIS Corporation (2024) Summary page 6.

## Indications for use
The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope’s air/water channel post-procedure, and not to be used during a patient procedure.

Source page: https://510kreport.com/device/K243075
Methodology: https://510kreport.com/methodology