510(k) · Cleared
ClearedBarosense Endogastric Tube and Introducer Bougie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barosense, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 10, 2012 as substantially equivalent to K082589 (Barosense, Inc., 2009) after a 237-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 10, 2012
- Review
- 237 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942044 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 2 generations backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- 1 generation backK082589 Barosense Endogastric Tube (Egt), Model F0034Barosense, Inc. · 2009
- This deviceK120126 Barosense Endogastric Tube and Introducer BougieBarosense, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −2 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| −1 | K082589 | Barosense Endogastric Tube (Egt), Model F0034 | Barosense, Inc. | 2009 | — |
| 0 (this device) | K120126 | Barosense Endogastric Tube and Introducer Bougie | Barosense, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K082589 | Barosense Endogastric Tube (Egt), Model F0034Summary page 2…ices Manufacturer Predicate device 510(k) BaroSense, Inc. Endogastric Tube (EGT) K082589 Redwood City, CA Device Description The EGT is a reusable overtube used in hospitals or surgery centers to provide… | 2009 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 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. 2012, 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 BaroSense Endogastric Tube (BUT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120126: Barosense Endogastric Tube and Introducer Bougie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120126
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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