# K960176: Davol Nasogastric Sump Tube W/Prevent Filter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 24, 1996 after 190 days
- Product code: FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Salem Sump Tube with Anti-Reflux Valve: named in the summary without a submission number

## Most influential descendants
- K040388: Next Generation Salem Sump (2004), 5 descendants of its own
- K150711: Salem Sump Dual Lumen Stomach Tube with Multi-functional Port (2015), 3 descendants of its own
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection (2019), 2 descendants of its own
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own
- K213174: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (2022), 0 descendants of its own

## Recalls of this device
- Dec 20, 2023 · Class II · Z-0791-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0795-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0804-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0794-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0802-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0792-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0793-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0797-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0798-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0799-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0800-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0801-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0806-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0790-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0796-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0803-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Dec 20, 2023 · Class II · Z-0805-2024: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

## Indications for use
The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.

Source page: https://510kreport.com/device/K960176
Methodology: https://510kreport.com/methodology