510(k) · Cleared
ClearedNaviaid (TM) BGC 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 Aug 9, 2011 as substantially equivalent to K102616 (Smart Medical Systems, Ltd., 2010) and 1 other predicate after a 48-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Aug 9, 2011
- Review
- 48 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K993704 (2000). 9 ancestors in all, the oldest K944759 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 2 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 1 generation backK102616 Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd. · 2010
- This deviceK111760 Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK232327 EndorailEndostart S.R.L. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232327EndorailEndostart S.R.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −3 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −2 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −1 | K102616 | Naviaid Balloon Guided Colonoscopy (BGC) Device | Smart Medical Systems, Ltd. | 2010 | — |
| 0 (this device) | K111760 | Naviaid (TM) BGC Device | Smart Medical Systems, Ltd. | 2011 | — |
| +1 | K232327 | Endorail | Endostart S.R.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K102616 | Naviaid Balloon Guided Colonoscopy (BGC) DeviceSummary page 2…d NaviAid TmBGC device is substantially equivalent to the cleared NaviAidTm BGC device (manufactured by Smart Medical Systems Ltd. and the subject of 510(k) document no. K102616) and to the cleared NaviAidTM ICVL device (manufactured by Smart Medical Systems Ltd. and the subject of 510(k) document no. Ki11… | 2010 |
| * | K110291 | Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceSummary page 3…ive component to the ASU. The SB ASU component of the modified NaviAidTM BG device is identical to the SB ASU component of the cleared NaviAidTM ICVI Device (K110291) and their technological characteristic are the identical. The BG Disposable was not changed or altered and therefore the modifie… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232327 | Endorail | 2024 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K232327 (Endostart S.R.L., 2024) has gone furthest, with 0 descendants of its own.
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 BGC device is an accessory to an endoscope and is intended to ensure
positioning of a standard endoscope during endoscopy of the small and large intestine
(standard endoscope-i.e., an endoscope that has an instrument channel that is at least
3.7mm diameter and is used for standard endoscopic visualization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111760: Naviaid (TM) BGC Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111760
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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