# K250296: Disposable Distal Attachment D-201 Series

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: May 1, 2025 after 90 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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: 3 generations back to K853585 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, Olympus America, Inc. (1999) Summary page 5.

## Most influential descendants
- K260856: Disposable Distal Attachment D-201-13404 (2026), 0 descendants of its own

## Indications for use
The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope’s view field within the gastrointestinal tract.

Source page: https://510kreport.com/device/K250296
Methodology: https://510kreport.com/methodology