# K820442: Argyle Indwell Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Mar 10, 1982 after 20 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K150084: Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (2015), 6 descendants of its own
- K092628: Enteral Feeding Tube and Accessories, Feeding Tube Extension Set (2010), 2 descendants of its own
- K213258: Nasogastric Feeding Tubes - ENFit Port - PVC (2022), 1 descendant of its own
- K210598: Pediatric Nasogastric Feeding Tubes - Single ENFit Port (2021), 1 descendant of its own
- K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (2019), 1 descendant of its own

## Recalls of this device
- Jan 21, 2016 · Class II · Z-1033-2016: 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
- Jan 21, 2016 · Class II · Z-1034-2016: 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs

Source page: https://510kreport.com/device/K820442
Methodology: https://510kreport.com/methodology