# K123421: Olympus Small Intestinal Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 29, 2013 after 174 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090210 (2009). 1 ancestor in all.
4 later devices descend 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)
- K090210: Modification to Olympus Capsule Endoscope System, Olympus Medical Systems Corporation (2009) Summary page 2.

## Most influential descendants
- K142680: Endocapsule Software 10; Endocapsule Software 10 Light (2015), 3 descendants of its own
- K163069: Olympus Small Intestinal Capsule Endoscope System (2017), 2 descendants of its own
- K173459: Olympus Small Intestinal Capsule Endoscope System (2018), 1 descendant of its own
- K183053: Olympus Small Intestinal Capsule Endoscope System (2019), 0 descendants of its own

## Indications for use
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.

Source page: https://510kreport.com/device/K123421
Methodology: https://510kreport.com/methodology