510(k) · Cleared
ClearedLopez Valve with NG Sump Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Cleared on Oct 26, 1992 after a 231-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 26, 1992
- Review
- 231 days
- Class
- Class II
- Product code
- FEG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK921104 Lopez Valve with NG Sump TubeIcu 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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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) | K921104 | Lopez Valve with NG Sump Tube | 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 |
| 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040388 | Next Generation Salem Sump | 2004 | 5 |
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/K921104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921104: Lopez Valve with NG 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/K921104
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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