# K101191: Naviaid Icvi Device

- Pathway: 510(k) (Traditional)
- Applicant: Smart Medical Systems, Ltd.
- Decided: Jul 27, 2010 after 90 days
- Product code: FDF (Colonoscope 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
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
- K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device (2011), 3 descendants of its own
- K102616: Naviaid Balloon Guided Colonoscopy (BGC) Device (2010), 2 descendants of its own
- K111760: Naviaid (TM) BGC Device (2011), 1 descendant of its own
- K232327: Endorail (2024), 0 descendants of its own
- K112106: Naviaid Icvi-F,S,B,R Device (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K101191
Methodology: https://510kreport.com/methodology