510(k) · Decided
DecidedPathfinder® CR System
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 Jun 27, 2024 as substantially equivalent to K211301 (Neptune Medical, Inc., 2021) and 1 other predicate after a 91-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Jun 27, 2024
- Review
- 91 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K921244 (1992). 39 ancestors in all, the oldest K822846 (1982). No later device cites it as a predicate yet.
- Root · 14 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 10 generations between
- 3 generations backK191220 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019
- 2 generations backK220007 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2022
- 1 generation backK232922 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2023
- This deviceK240853 Pathfinder® CR SystemNeptune Medical, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 13 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 12 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 11 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 10 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 9 generations backK091305 ClearpathEasyglide, Ltd. · 2009
- 8 generations backK093779 Clearpath UgiEasyglide, Ltd. · 2010
- 7 generations backK113050 Clearpath Lower GIEasyglide, Ltd. · 2012
- 6 generations backK160015 Pure VuMotus GI Medical Technologies, Ltd. · 2016
- 5 generations backK173392 Pure-Vu SystemMotus GI Medical Technologies, Ltd. · 2017
- 4 generations backK181437 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2018
- 3 generations backK191220 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019
- 2 generations backK220007 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2022
- 1 generation backK232922 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2023
- This deviceK240853 Pathfinder® CR SystemNeptune Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −13 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −12 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −11 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −10 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −9 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| −8 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| −7 | K113050 | Clearpath Lower GI | Easyglide, Ltd. | 2012 | — |
| −6 | K160015 | Pure Vu | Motus GI Medical Technologies, Ltd. | 2016 | — |
| −5 | K173392 | Pure-Vu System | Motus GI Medical Technologies, Ltd. | 2017 | — |
| −4 | K181437 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2018 | — |
| −3 | K191220 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2019 | — |
| −2 | K220007 | Pure-Vu EVS System | Motus GI Medical Technologies, Ltd. | 2022 | — |
| −1 | K232922 | Pure-Vu EVS System | Motus GI Medical Technologies, Ltd. | 2023 | — |
| 0 (this device) | K240853 | Pathfinder® CR System | Neptune Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 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 |
|---|---|---|---|
| * | K211301 | Pathfinder Endoscope OvertubeSummary page 5…Review Panel: Gastroenterology and Urology Primary Predicate Device: Trade/Device Name: Pathfinder Endoscope Overtube (K211301) Manufacturer: Neptune Medical, Inc. Common Name: Endoscopic Access Ov… | 2021 |
| * | K232922 | Pure-Vu EVS SystemSummary page 6…Page 2 of 7 Secondary Predicate Device: Trade/Device Name: Pure-Vu EVS System (K232922) Manufacturer: Motus GI Medical Technologies Ltd. Common Name: Pure-… | 2023 |
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 32 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 39 ancestors have a recall of any class.
- 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. 2024, 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® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be
used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid
from the stomach in adult patients (22 years of age or older).
It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics
and doctors’ offices.
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/K240853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240853: Pathfinder® CR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240853
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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