510(k) · Cleared
Recalled · Class II · 2019Kangaroo Enteral Feeding Set with Enfit Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · LZH Pump, Infusion, Enteral
Cleared on Dec 23, 2014 as substantially equivalent to K040196 (Tyco Healthcare/Kendall, 2004) after a 202-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 3 times.
- Decided
- Dec 23, 2014
- Review
- 202 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945964 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- 1 generation backK040196 Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsTyco Healthcare/Kendall · 2004 · Recalled
- This deviceK141479 Kangaroo Enteral Feeding Set with Enfit ConnectorsCovidien · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| −1 | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets | Tyco Healthcare/Kendall | 2004 | 5 |
| 0 (this device) | K141479 | Kangaroo Enteral Feeding Set with Enfit Connectors | Covidien | 2014 | — |
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 LZH? 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 LZH device
- #1 K253558 Luminoah FLOW™ Enteral Nutrition Systemscore 13.0 · 7 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 |
|---|---|---|---|
| * | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsSummary page 4…oo™ Enteral Feeding Set with ENFit connectors c. Identification of Legally Marketed Device(s) Covidien Kangaroo™ ePump Enteral Feeding Pump and Enteral Feeding Set, K040196 d. Device comparison summary The table below provides a comparison of the key attributes of the predicate and proposed d… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2019 | Class II | Z-2100-2020 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Dec 26, 2019 | Class II | Z-2101-2020 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Dec 26, 2019 | Class II | Z-2105-2020 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040196.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZH
Too few LZH 510(k)s in any year since 2007 to give a median.
Recalls per year · LZH
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZH
376in 2025
MAUDE reports naming product code LZH, 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 | — | 2 | 1,150 |
| 2008 | 0 | — | 3 | 858 |
| 2009 | 0 | — | 1 | 124 |
| 2010 | 0 | — | 0 | 220 |
| 2011 | 0 | — | 1 | 274 |
| 2012 | 1 | — | 2 | 398 |
| 2013 | 0 | — | 0 | 349 |
| 2014 | 2 | — | 0 | 119 |
| 2015 | 1 | — | 0 | 83 |
| 2016 | 1 | — | 0 | 1,248 |
| 2017 | 0 | — | 0 | 2,620 |
| 2018 | 0 | — | 0 | 1,652 |
| 2019 | 0 | — | 0 | 742 |
| 2020 | 1 | — | 2 | 1,460 |
| 2021 | 0 | — | 0 | 1,218 |
| 2022 | 2 | — | 0 | 526 |
| 2023 | 1 | — | 0 | 284 |
| 2024 | 0 | — | 0 | 319 |
| 2025 | 0 | — | 0 | 376 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141479: Kangaroo Enteral Feeding Set with Enfit Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141479
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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