510(k) · Cleared
Recalled · Class II · 2025Argyle Salem Sump Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Mar 2, 1981 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 2, 1981
- Review
- 40 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 3
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981
- Descendant · cites it directly · 8 of its ownK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
- Descendant · 2 generations on · 7 of its ownK020005 Infant Feeding TubesPromedic, Inc. · 2002
- Descendant · 3 generations on · 6 of its ownK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- Descendant · 4 generations on · 5 of its ownK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- Descendant · 4 generations on · 4 of its ownK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K971354Knott NG TubeMichael M. Knott, M.D. · 1997 · cites it directly8descendants
- K020005Infant Feeding TubesPromedic, Inc. · 2002 · 2 generations on7descendants
- K052903Pediatric Feeding TubePromedic, Inc. · 2005 · 3 generations on6descendants
- K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007 · 4 generations on5descendants
- K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC · 2009 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810156 | Argyle Salem Sump Tube | Sherwood Medical Co. | 1981 | — |
| +1 | K971354 | Knott NG Tube | Michael M. Knott, M.D. | 1997 | — |
| +2 | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| +3 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| +4 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| +4 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class II | Z-0207-2026 | Use error | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. |
| Jul 24, 2024 | Class II | Z-3301-2024 | Labeling Change Control | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| Oct 31, 2018 | Class II | Z-0597-2019 | Under Investigation by firm | This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971354 (Michael M. Knott, M.D., 1997) has gone furthest, with 8 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
https://510kreport.com/device/K810156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810156: Argyle Salem Sump Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810156
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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