510(k) · Cleared
ClearedNaviaid Icvi Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Medical Systems, Ltd. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jul 27, 2010 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 27, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK101191 Naviaid Icvi DeviceSmart Medical Systems, Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK110291 Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceSmart Medical Systems, Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK102616 Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK111760 Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK232327 EndorailEndostart S.R.L. · 2024
- Descendant · 2 generations on · 0 of its ownK112106 Naviaid Icvi-F,S,B,R DeviceSmart Medical Systems, Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K110291Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceSmart Medical Systems, Ltd. · 2011 · cites it directly3descendants
- K102616Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd. · 2010 · cites it directly2descendants
- K111760Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd. · 2011 · 2 generations on1descendant
- K232327EndorailEndostart S.R.L. · 2024 · 3 generations on0descendants
- K112106Naviaid Icvi-F,S,B,R DeviceSmart Medical Systems, Ltd. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101191 | Naviaid Icvi Device | Smart Medical Systems, Ltd. | 2010 | — |
| +1 | K110291 | Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device | Smart Medical Systems, Ltd. | 2011 | — |
| +1 | K102616 | Naviaid Balloon Guided Colonoscopy (BGC) Device | Smart Medical Systems, Ltd. | 2010 | — |
| +2 | K111760 | Naviaid (TM) BGC Device | Smart Medical Systems, Ltd. | 2011 | — |
| +3 | K232327 | Endorail | Endostart S.R.L. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K110291 (Smart Medical Systems, Ltd., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
https://510kreport.com/device/K101191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101191: Naviaid Icvi Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101191
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026