510(k) · Cleared
ClearedSalem Sump Silicone 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 May 19, 2022 as substantially equivalent to K190923 (Cardinalhealth, 2019) after a 233-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- May 19, 2022
- Review
- 233 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915171 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK915171 Lopez Valve TM IIIcu Medical, Inc. · 1992
- 3 generations backK040388 Next Generation Salem SumpKendall · 2004
- 2 generations backK150711 Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015
- 1 generation backK190923 Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019 · Recalled
- This deviceK213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915171 | Lopez Valve TM II | Icu Medical, Inc. | 1992 | — |
| −3 | K040388 | Next Generation Salem Sump | Kendall | 2004 | — |
| −2 | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Covidien | 2015 | — |
| −1 | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionSummary page 4…Regulation Number: 21 CFR 876.5980 Product Code: PIF; FEG Class: II Identification of Predicate Device: 510(k) Number K190923 Salem Sump Dual Lumen Stomach Tube with ENFit™ Device Description C… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 11.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K190923.
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. 2022, 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™ Silicone 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/K213174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213174: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213174
Report an extraction error
Are you the manufacturer?
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