510(k) · Cleared
Recalled · Class II · 2016Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · LZH Pump, Infusion, Enteral
Cleared on May 29, 2015 as substantially equivalent to K040196 (Tyco Healthcare/Kendall, 2004) after a 197-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- May 29, 2015
- Review
- 197 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945964 (1995). 4 later devices descend from it, 2 citing it directly.
- 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 deviceK143263 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2015
- Descendant · cites it directly · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK253558 Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026
- Descendant · 2 generations on · 0 of its ownK221603 Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding…Cardinal Health, LLC · 2022
- Descendant · cites it directly · 0 of its ownK200051 PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · cites it directly2descendants
- K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026 · 2 generations on0descendants
- K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC · 2022 · 2 generations on0descendants
- K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020 · cites it directly0descendants
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) | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015 | — |
| +1 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
| +2 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026 | — |
| +2 | K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml… | Cardinal Health, LLC | 2022 | — |
| +1 | K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 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…Connect Feeding Sets c. Identification of Legally Marketed Device(s) Covidien Kangaroo™ ePump Enteral Feeding Pump and Enteral Feeding Set, K040196 d. Device Brief Description The table below provides a comparison of the key attributes of the predicate and proposed de… | 2004 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2016 | Class II | Z-1649-2016 | Device Design | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm |
| Apr 1, 2016 | Class II | Z-1648-2016 | Device Design | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K153074 (Covidien, 2016) has gone furthest, with 2 descendants of its own.
- 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. 2015, 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™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets 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 pump and feeding sets are intended to be used in clinical or home care settings by users ranging
from laypersons to clinicians.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143263: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143263
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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