510(k) · Cleared
ClearedNaviaid Balloon Guided Colonoscopy (BGC) 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 Dec 30, 2010 as substantially equivalent to K101191 (Smart Medical Systems, Ltd., 2010) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 30, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K993704 (2000). 7 ancestors in all, the oldest K944759 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 2 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 1 generation backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- This deviceK102616 Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd. · 2010
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −2 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −1 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| 0 (this device) | K102616 | Naviaid Balloon Guided Colonoscopy (BGC) Device | Smart Medical Systems, Ltd. | 2010 | — |
| +1 | K111760 | Naviaid (TM) BGC Device | Smart Medical Systems, Ltd. | 2011 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K101191 | Naviaid Icvi Device | 2010 |
| * | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Summary page 2…Medical Systems Ltd. and the subject of 510(k) document no. KI1l1191) and the Double Balloon Colonoscope (manufactured by Fujinon and the subject of 5 10(k) document no. K0901 16). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description: The NaviAidr… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111760 | Naviaid (TM) BGC Device | 2011 | 1 |
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 10 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K111760 (Smart Medical Systems, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101191.
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 | — |
What is it indicated for?
The NaviAidTm BUC 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 3.7mmn diameter and is used for standard endoscopic visualization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102616: Naviaid Balloon Guided Colonoscopy (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/K102616
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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