510(k) · Decided
DecidedArgyle Salem Sump Tube Anti-Reflux Valve Insertion Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Cleared on Jan 27, 1995 after a 417-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 27, 1995
- Review
- 417 days
- Class
- Class II
- Product code
- FEG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK935781 Argyle Salem Sump Tube Anti-Reflux Valve Insertion TraySherwood Medical Co. · 1995
- Descendant · cites it directly · 5 of its ownK040388 Next Generation Salem SumpKendall · 2004
- Descendant · 2 generations on · 3 of its ownK150711 Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015
- Descendant · 3 generations on · 2 of its ownK190923 Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040388Next Generation Salem SumpKendall · 2004 · cites it directly5descendants
- K150711Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015 · 2 generations on3descendants
- K190923Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019 · 3 generations on2descendants
- K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023 · 4 generations on0descendants
- K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935781 | Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray | Sherwood Medical Co. | 1995 | — |
| +1 | K040388 | Next Generation Salem Sump | Kendall | 2004 | — |
| +2 | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Covidien | 2015 | — |
| +3 | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019 | 1 |
| +4 | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
| +4 | K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040388 (Kendall, 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FEG devicesFEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEG
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FEG
Too few FEG 510(k)s in any year since 2007 to give a median.
Recalls per year · FEG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEG
46in 2025
MAUDE reports naming product code FEG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 36 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 10 | 33 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 2 | 46 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935781: Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935781
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026