510(k) · Cleared
Recalled · Class II · 2021Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare/Kendall · LZH Pump, Infusion, Enteral
Cleared on May 5, 2004 as substantially equivalent to K945964 (Sherwood Medical Co., 1995) after a 97-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- May 5, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945964 (1995). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- This deviceK040196 Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsTyco Healthcare/Kendall · 2004
- Descendant · cites it directly · 4 of its ownK143263 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK253558 Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026
- Descendant · 3 generations on · 0 of its ownK221603 Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding…Cardinal Health, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK200051 PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143263Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsCovidien · 2015 · cites it directly4descendants
- K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · 2 generations on2descendants
- K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026 · 3 generations on0descendants
- K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC · 2022 · 3 generations on0descendants
- K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| 0 (this device) | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets | Tyco Healthcare/Kendall | 2004 | — |
| +1 | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015 | 2 |
| +2 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
| +3 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026 | — |
| +3 | K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml… | Cardinal Health, LLC | 2022 | — |
| +2 | K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSummary page 1…antially equivalent in intended use, function and mode of operation to the currently marketed Kangaroo® 524 Enteral Feeding Pump & Administration Sets (K945964). 4. Device Description The ePumpTM platform is a new enteral feeding system comprised of an enteral feeding pump… | 1995 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | 2015 | 4 |
| K141479 | Kangaroo Enteral Feeding Set with Enfit Connectors | 2014 | 0 |
| K060316 | Compat GO Enteral Feeding Pump and Administration Sets | 2006 | 0 |
| K053410 | Gientriport with Universal Single Lumen Adaptor | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2021 | Class II | Z-1347-2021 | Process control | The potential for air appearing in the enteral feed pumping set tubing during set-up. |
| Dec 26, 2019 | Class II | Z-2103-2020 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Dec 26, 2019 | Class II | Z-2104-2020 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding, pump and pump set. The pump and feeding sets are intended to be used in alternate, acute and home care settings by users ranging from laypersons to clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patients gastrointestinal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040196: Kendall Epump Enteral Feeding Pump and Enteral 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/K040196
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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