510(k) · Cleared
ClearedPathfinder Endoscope Overtube with Balloon Device
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 Jul 28, 2023 as substantially equivalent to K211301 (Neptune Medical, Inc., 2021) after a 127-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jul 28, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
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 deviceK230801 Pathfinder Endoscope Overtube with Balloon DeviceNeptune Medical, Inc. · 2023
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) | K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | 2023 | — |
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? (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 |
|---|---|---|---|
| * | K211301 | Pathfinder Endoscope OvertubeSummary page 4…Class II Product Code: FED (21 CFR 876.1500) Predicate Device: Pathfinder Endoscope Overtube (K211301) Reference Device: Dilumen Endolumenal Interventional Platform (K210851) 1.4 Predicate/Reference… | 2021 |
| † | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | 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 19 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K211301.
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. 2023, 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 with Balloon 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 as stated in the FDA summary.
https://510kreport.com/device/K230801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230801: Pathfinder Endoscope Overtube with Balloon Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230801
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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