510(k) · Cleared
ClearedLopez Valve TM II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 7, 1992 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 7, 1992
- Review
- 84 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK915171 Lopez Valve TM IIIcu Medical, Inc. · 1992
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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) | K915171 | Lopez Valve TM II | Icu Medical, Inc. | 1992 | — |
| +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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
4 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 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/K915171 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915171: Lopez Valve TM II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915171
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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