510(k) · Cleared
ClearedNaviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B 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 Jun 17, 2011 as substantially equivalent to K101191 (Smart Medical Systems, Ltd., 2010) after a 136-day review. Its family tree reaches back 1 generation to 2010. 3 later devices descend from it.
- Decided
- Jun 17, 2011
- Review
- 136 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101191 (2010). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK101191 Naviaid Icvi DeviceSmart Medical Systems, Ltd. · 2010
- This deviceK110291 Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceSmart Medical Systems, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK111760 Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK232327 EndorailEndostart S.R.L. · 2024
- Descendant · cites it directly · 0 of its ownK112106 Naviaid Icvi-F,S,B,R DeviceSmart Medical Systems, Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101191 | Naviaid Icvi Device | Smart Medical Systems, Ltd. | 2010 | — |
| 0 (this device) | K110291 | Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device | Smart Medical Systems, Ltd. | 2011 | — |
| +1 | K111760 | Naviaid (TM) BGC Device | Smart Medical Systems, Ltd. | 2011 | — |
| +2 | K232327 | Endorail | Endostart S.R.L. | 2024 | — |
| +1 | K112106 | Naviaid Icvi-F,S,B,R Device | Smart Medical Systems, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
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.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ICVT 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 has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110291
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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