510(k) · Cleared
ClearedBarosense Endogastric Tube (Egt), Model F0034
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 May 22, 2009 as substantially equivalent to K040836 (United States Endoscopy Group, Inc., 2004) and 2 other predicates after a 256-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- May 22, 2009
- Review
- 256 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942044 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 1 generation backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- This deviceK082589 Barosense Endogastric Tube (Egt), Model F0034Barosense, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK120126 Barosense Endogastric Tube and Introducer BougieBarosense, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120126Barosense Endogastric Tube and Introducer BougieBarosense, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −1 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| 0 (this device) | K082589 | Barosense Endogastric Tube (Egt), Model F0034 | Barosense, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K040836 | Disposable OvertubeSummary page 2…CONFIDENTIAL SubstantiallyEquivalent Devices US Endoscopy GuardusTM Disposable Overtube K040836 Mentor, OH NDO Surgical Overtube K002018 Mansf… | 2004 |
| * | K002018 | Ndo Surgical Surgical OvertubeSummary page 2…GuardusTM Disposable Overtube K040836 Mentor, OH NDO Surgical Overtube K002018 Mansfield, MA CR Bard, Inc. Endoscopic Overtube K973500 Bil… | 2000 |
| * | K973500 | Bard Endoscopic Overtube (#000307)Summary page 2…Overtube K002018 Mansfield, MA CR Bard, Inc. Endoscopic Overtube K973500 Billerica, MA Device Description The BaroSense EGT is a single use, disposable, overtube used in hospitals or surger… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120126 | Barosense Endogastric Tube and Introducer Bougie | 2012 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120126 (Barosense, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K040836.
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. 2009, 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 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/K082589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082589: Barosense Endogastric Tube (Egt), Model F0034.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082589
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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