510(k) · Cleared
ClearedUsgi Transport Endoscopic Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usgi Medical · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 13, 2007 as substantially equivalent to K061216 (Usgi Medical, 2006) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 13, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942044 (1994). 7 ancestors in all, the oldest K903842 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 3 generations backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- 2 generations backK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- 1 generation backK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- This deviceK072405 Usgi Transport Endoscopic Access DeviceUsgi Medical · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −3 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| −2 | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| −1 | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| 0 (this device) | K072405 | Usgi Transport Endoscopic Access Device | Usgi Medical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K061216 | Usgi Transport Endoscopic GuideSummary page 1…3. IDENTIFICATION OF PREDICATE DEVICES TransPort T' Endoscopic Access Device USGI Medical (K061216) ShapeLock T' Endoscopic Access Device USGI Medical (K… | 2006 |
| * | K033954 | Shape Locking Endoscopic OvertubeSummary page 1…(K061216) ShapeLock T' Endoscopic Access Device USGI Medical (K033954) 32 US1l Medical Special 510(k) Device Modification… | 2004 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K061216.
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. 2007, 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 USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072405: Usgi Transport Endoscopic Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072405
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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