# K090210: Modification to Olympus Capsule Endoscope System

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 29, 2009 after 182 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
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123421: Olympus Small Intestinal Capsule Endoscope System (2013), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K090210
Methodology: https://510kreport.com/methodology