510(k) · Cleared
ClearedEndoguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kms Medical, LLC · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jan 31, 2007 as substantially equivalent to K040836 (United States Endoscopy Group, Inc., 2004) after a 54-day review. Its family tree reaches back 1 generation to 2004. 7 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 54 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040836 (2004). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- This deviceK063654 EndoguideKms Medical, LLC · 2007
- Descendant · cites it directly · 6 of its ownK191415 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK211301 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK230752 Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK262262 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243091 Over-tube (TR-1108A)Fujifilm Corporation · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019 · cites it directly6descendants
- K211301Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2021 · 2 generations on3descendants
- K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FUJIFILM Healthcare Americas Corporation · 2023 · 2 generations on1descendant
- K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026 · 2 generations on0descendants
- K243091Over-tube (TR-1108A)Fujifilm Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| 0 (this device) | K063654 | Endoguide | Kms Medical, LLC | 2007 | — |
| +1 | K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2019 | — |
| +2 | K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021 | — |
| +2 | K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +2 | K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2026 | — |
| +3 | K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K040836 | Disposable OvertubeSummary page 1…21 CFR 876.1500 Class: 11 Product Code: KOG Predicate Device: US Endoscopy Group, GuardUSTM Overtube, K(040836 Device Description: The EndoGuide fits over a pediatric colonoscope and can be… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191415 | Pathfinder Endoscope Overtube | 2019 | 6 |
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 FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063654 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063654: Endoguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063654
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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