510(k) · Cleared
ClearedOver-tube (TR-1108A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Nov 1, 2024 as substantially equivalent to K230752 (FUJIFILM Healthcare Americas Corporation, 2023) after a 32-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Nov 1, 2024
- Review
- 32 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 backK230752 Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FUJIFILM Healthcare Americas Corporation · 2023
- This deviceK243091 Over-tube (TR-1108A)Fujifilm Corporation · 2024
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 | K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| 0 (this device) | K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 2024 | — |
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 |
|---|---|---|---|
| * | K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)Summary page 5…876.1500 Product Code(s) FED I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K230752 Over-tube (TR-1208A) FED Device Description Summary 21 CFR 807.92(a)(4) A. Intended Use/indications for Use endoscopic treatmen… | 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 20 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
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?
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
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/K243091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243091: Over-tube (TR-1108A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243091
Report an extraction error
Are you the manufacturer?
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