510(k) · Cleared

Cleared

Next Generation Salem Sump

K040388510(k) TraditionalCleared May 17, 200490-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kendall · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Cleared on May 17, 2004 as substantially equivalent to K935781 (Sherwood Medical Co., 1995) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: May 17, 2004
Review: 90 days
Class: Class II
Product code: FEG
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K915171 (1992). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK915171 Lopez Valve TM IIIcu Medical, Inc. · 1992
This deviceK040388 Next Generation Salem SumpKendall · 2004
Descendant · cites it directly · 3 of its ownK150711 Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015
Descendant · 2 generations on · 2 of its ownK190923 Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019 · Recalled
Descendant · 3 generations on · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
Descendant · 3 generations on · 0 of its ownK213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022
Descendant · cites it directly · 0 of its ownK053410 Gientriport with Universal Single Lumen AdaptorKendall · 2006

Most influential descendants

Showing 5 of 5 · See all

K150711Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien · 2015 · cites it directly3descendants
K190923Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2019 · 2 generations on2descendants
K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023 · 3 generations on0descendants
K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth · 2022 · 3 generations on0descendants
K053410Gientriport with Universal Single Lumen AdaptorKendall · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915171	Lopez Valve TM II	Icu Medical, Inc.	1992	—
0 (this device)	K040388	Next Generation Salem Sump	Kendall	2004	—
+1	K150711	Salem Sump Dual Lumen Stomach Tube with Multi-functional Port	Covidien	2015	—
+2	K190923	Salem Sump Dual Lumen Stomach Tube with ENFit Connection	Cardinalhealth	2019	1
+3	K222846	AMT G-Tube Balloon Gastrostomy Feeding Device	Applied Medical Technology, Inc.	2023	—
+3	K213174	Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection	Cardinalhealth	2022	—
+1	K053410	Gientriport with Universal Single Lumen Adaptor	Kendall	2006	—

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
2006	1	0
2015	1	0
2019	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K040388, 1992–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K935781	Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray Summary page 1 …Gastroenterology Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Kendall Salem Sump (naso gastric) tube with Anti-Reflux Valve, 510(k) number K935781/A, cleared on January 10, 1995. Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter, 510(k) number K96017…	Sherwood Medical Co.	1995	—
*	K960176	Davol Nasogastric Sump Tube W/Prevent Filter Summary page 1 …with Anti-Reflux Valve, 510(k) number K935781/A, cleared on January 10, 1995. Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter, 510(k) number K960176, cleared on July 24, 1996. ICU Medical Lopez Valve, 510(k) number K915171, cleared February 7, 1992 ICU Medical Lopez Val…	C.R. Bard, Inc.	1996	17
*	K915171	Lopez Valve TM II Summary page 1 …95. Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter, 510(k) number K960176, cleared on July 24, 1996. ICU Medical Lopez Valve, 510(k) number K915171, cleared February 7, 1992 ICU Medical Lopez Valve with NG tube, 510(k) number K921104, cleared on October 26, 1992.…	Icu Medical, Inc.	1992	—
*	K921104	Lopez Valve with NG Sump Tube Summary page 1 …K960176, cleared on July 24, 1996. ICU Medical Lopez Valve, 510(k) number K915171, cleared February 7, 1992 ICU Medical Lopez Valve with NG tube, 510(k) number K921104, cleared on October 26, 1992.…	Icu Medical, Inc.	1992	—

Also cleared against K935781: 1 other device →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150711	Salem Sump Dual Lumen Stomach Tube with Multi-functional Port	Covidien	2015	3
K053410	Gientriport with Universal Single Lumen Adaptor	Kendall	2006	0

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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K150711 (Covidien, 2015) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K935781.

How does its category compare?

All FEG devices

FEG 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

2007high 1 (2013) · low 0 (2007)2026

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

2007high 10 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FEG

46in 2025

2007high 46 (2025) · low 0 (2007)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	—

What is it indicated for?

The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040388 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040388: Next Generation Salem Sump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040388

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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