510(k) · Cleared
ClearedNaviaid Icvi-F,S,B,R Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Medical Systems, Ltd. · ODC Endoscope Channel Accessory
Cleared on Feb 6, 2012 as substantially equivalent to K110291 (Smart Medical Systems, Ltd., 2011) after a 199-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Feb 6, 2012
- Review
- 199 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101191 (2010). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110291 | Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceSummary page 2…ified NaviAid TM ICVL device is substantially equivalent to the NaviAidTM ICVI device (manufactured by Smart Medical Systems Ltd. and the subject of 5l1O(k) document no. K 11029 1). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description: The modified N… | 2011 |
| † | K060923 | Naviaid Bge Device, Model 21-001 | 2006 |
| † | K101191 | Naviaid Icvi Device | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 11 months on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K110291.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The NaviAidTM ICVI device is an accessory to an endoscope and is intended to ensure
positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used
for standard intestinal endoscopic visualization and has a compatible instrument channel
as defined in the instructions for use)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112106: Naviaid Icvi-F,S,B,R Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026