510(k) · Cleared
ClearedArgyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jul 13, 2015 as substantially equivalent to K820441 (Sherwood Medical Co., 1982) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 1982. 6 later devices descend from it.
- Decided
- Jul 13, 2015
- Review
- 179 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820441 (1982). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK820441 Argyle PVC Feeding TubeSherwood Medical Co. · 1982
- This deviceK150084 Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU)…Covidien · 2015
- Descendant · cites it directly · 1 of its ownK213258 Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 2022
- Descendant · cites it directly · 1 of its ownK210598 Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl · 2021
- Descendant · cites it directly · 1 of its ownK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK233974 Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024
- Descendant · 2 generations on · 0 of its ownK222773 Feeding TubeAnhui Tiankang Medical Technology Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213258Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 2022 · cites it directly1descendant
- K210598Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl · 2021 · cites it directly1descendant
- K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019 · cites it directly1descendant
- K233974Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024 · 2 generations on0descendants
- K222773Feeding TubeAnhui Tiankang Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820441 | Argyle PVC Feeding Tube | Sherwood Medical Co. | 1982 | — |
| 0 (this device) | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and… | Covidien | 2015 | — |
| +1 | K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022 | — |
| +1 | K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021 | — |
| +1 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019 | — |
| +2 | K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024 | — |
| +2 | K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K820441 | Argyle PVC Feeding TubeSummary page 4…ng Tubes with ENFit Small Bore Connector c. Identification of Legally Marketed Device(s) Argyle Polyvinyl Chloride (PVC) Feeding Tubes, K820441 Argyle Indwell Polyurethane Feeding Tubes, K820442 d. Device Brief Description The Argyle™ Polyvinyl Chloride (PVC) and K… | 1982 |
| * | K820442 | Argyle Indwell Feeding TubeSummary page 4…Bore Connector c. Identification of Legally Marketed Device(s) Argyle Polyvinyl Chloride (PVC) Feeding Tubes, K820441 Argyle Indwell Polyurethane Feeding Tubes, K820442 d. Device Brief Description The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric F… | 1982 |
What descends from it? (6)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2015, 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 Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications.
The device is intended for pediatric patients who require enteral feeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150084: Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150084
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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