# K233762: SteroScope® Sterilization Technology System

- Pathway: 510(k) (Traditional)
- Applicant: Ideate Medical, Inc.
- Decided: Jun 27, 2024 after 216 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981625 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle, Advanced Sterilization Products (2012) Summary page 5.

## Indications for use
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: • ID of 1.0 mm or larger and a length of 3580 mm or shorter and • ID of 1.2 mm or larger and a length of 4095 mm or shorter

Source page: https://510kreport.com/device/K233762
Methodology: https://510kreport.com/methodology