# K832458: Automatic Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: American Endoscopy, Inc.
- Decided: Oct 20, 1983 after 86 days
- Product code: NVE (Washer, Cleaner, Automated, Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 19, 2010 · Not classified · Z-0628-2011: The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result o
- Sep 11, 2008 · Not classified · Z-0281-2009: Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor. If high-level disinfectant, or other fluids, remains in the end

Source page: https://510kreport.com/device/K832458
Methodology: https://510kreport.com/methodology