510(k) · Cleared
ClearedPathfinder Endoscope Overtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neptune Medical, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 18, 2026 as substantially equivalent to K191415 (Neptune Medical, Inc., 2019) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Sep 18, 2026
- Review
- 78 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K040836 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- 3 generations backK063654 EndoguideKms Medical, LLC · 2007
- 2 generations backK191415 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019
- 1 generation backK211301 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2021
- This deviceK262262 Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| −3 | K063654 | Endoguide | Kms Medical, LLC | 2007 | — |
| −2 | K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2019 | — |
| −1 | K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021 | — |
| 0 (this device) | K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2026 | — |
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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K191415 | Pathfinder Endoscope OvertubeSummary page 5…ary Product Code FED Review Panel Gastroenterology and Urology Predicate Device Clearance K191415 and K211301 Trade/Device Name Pathfinder Endoscope Overtube Manufacturer… | 2019 |
| * | K211301 | Pathfinder Endoscope OvertubeSummary page 5…Code FED Review Panel Gastroenterology and Urology Predicate Device Clearance K191415 and K211301 Trade/Device Name Pathfinder Endoscope Overtube Manufacturer Nep… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K191415.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262262: Pathfinder Endoscope Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262262
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026