# K171692: Instrument basket, for EndoEYE

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Apr 2, 2018 after 299 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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 K844002 (1984). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 6.

## Most influential descendants
- K203492: Instrument tray, for semi-rigid ureteroscope (2021), 0 descendants of its own

## Indications for use
The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles: • Prevacuum steam sterilization - Exposure time at a temperature of 132 °C (269.6 °F:) Wrapped instruments 4 min. Immediate-use non-porous instruments 3 min. - Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments 3 min. Immediate-use non-porous instruments 3 min. - Drying time 30 min. After steam sterilization, let the instrument basket cool down at room temperature. - Cool-down time 30 min. • STERRAD® sterilization - STERRAD® 100S cycle - STERRAD® 100NX™: standard cycle and express cycle The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories. Validated worst-case load The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).

Source page: https://510kreport.com/device/K171692
Methodology: https://510kreport.com/methodology