510(k) · Cleared
Recalled · Class II · 2025Salem Sump Dual Lumen Stomach Tube with ENFit Connection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Nov 7, 2019 as substantially equivalent to K150711 (Covidien, 2015) after a 212-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2019
- Review
- 212 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915171 (1992). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK915171 Lopez Valve TM IIIcu Medical, Inc. · 1992
- 2 generations backK040388 Next Generation Salem SumpKendall · 2004
- 1 generation backK150711 Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015
- This deviceK190923 Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019
- Descendant · cites it directly · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915171 | Lopez Valve TM II | Icu Medical, Inc. | 1992 | — |
| −2 | K040388 | Next Generation Salem Sump | Kendall | 2004 | — |
| −1 | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Covidien | 2015 | — |
| 0 (this device) | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019 | — |
| +1 | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
| +1 | K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional PortSummary page 4…Number: 21 CFR 876.5980 Product Code: PIF; FEG Class: II Identification of Predicate Device: 510(k) Number K150711 Salem Sump Dual Lumen Stomach Tube with Multi- Device Description… | 2015 |
| † | K935781 | Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray | 1995 |
| † | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric… | 2015 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class II | Z-0206-2026 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K222846 (Applied Medical Technology, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190923
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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