510(k) · Cleared
Recalled · Class II · 2020Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · LZH Pump, Infusion, Enteral
Cleared on Jul 6, 2016 as substantially equivalent to K143263 (Covidien, 2015) and 1 other predicate after a 258-day review. Its family tree reaches back 6 generations to 2001. 8 of the 31 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 6, 2016
- Review
- 258 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 6 generations to K011442 (2001). 28 ancestors in all, the oldest K780880 (1978). 2 later devices descend from it, 2 citing it directly. 8 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 5 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 4 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 3 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- 2 generations backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- 1 generation backK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- This deviceK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016
- Descendant · cites it directly · 0 of its ownK253558 Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026
- Descendant · cites it directly · 0 of its ownK221603 Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding…Cardinal Health, LLC · 2022
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −5 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −4 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −3 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| −2 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| −1 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| 0 (this device) | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | — |
| +1 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026 | — |
| +1 | K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml… | Cardinal Health, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
8 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsSummary page 4…Infusion Pump Number: 21 CFR 880.5725 Class II Product Code: LZH Primary Predicate K143263 - Kangaroo™ Connect Enteral Feeding Pump with Device: Kangaroo™ Connect Feeding Sets Secondary Predicate… | 2015 |
| * | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Summary page 4…Primary Predicate K143263 - Kangaroo™ Connect Enteral Feeding Pump with Device: Kangaroo™ Connect Feeding Sets Secondary Predicate K141789 - Plum 360™ Infusion system with Hospira MedNet™ / Device: Smart Card Plug ‘n’ Play CE 3.0 Module Device De… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2020 | Class II | Z-0452-2021 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Sep 22, 2020 | Class II | Z-0453-2021 | Process control | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Dec 26, 2019 | Class II | Z-2102-2020 | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 17 Class I recalls
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 28 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K253558 (Luminoah, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143263.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 is intended to deliver 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 physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153074
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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