510(k) · Cleared
ClearedKangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, LLC · LZH Pump, Infusion, Enteral
Cleared on Dec 20, 2022 as substantially equivalent to K153074 (Covidien, 2016) after a 201-day review. Its family tree reaches back 7 generations to 2001. 8 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 20, 2022
- Review
- 201 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011442 (2001). 29 ancestors in all, the oldest K780880 (1978). No later device cites it as a predicate yet. 8 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 6 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 5 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 4 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- 3 generations backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- 2 generations backK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- 1 generation backK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
- This deviceK221603 Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding…Cardinal Health, LLC · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −6 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −5 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −4 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| −3 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| −2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| −1 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Summary page 6…Substantial Equivalence K221603 (current submission) K153074 Intended for delivery of enteral fluids, includin… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 3 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 · 3 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 · 4 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 5 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 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 22 of the 29 ancestors have a recall of any class; 8 have a Class I recall.
- 1 other device also cites its predicate K153074.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care…
Read the full statement (187 words)
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.
The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221603 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221603: Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221603
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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