510(k) · Cleared
ClearedPUGGLE Enteral Feeding Pump and Feeding Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · LZH Pump, Infusion, Enteral
Cleared on Sep 25, 2020 as substantially equivalent to K143263 (Covidien, 2015) after a 259-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Sep 25, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945964 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- 2 generations backK040196 Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsTyco Healthcare/Kendall · 2004 · Recalled
- 1 generation backK143263 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2015 · Recalled
- This deviceK200051 PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| −2 | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets | Tyco Healthcare/Kendall | 2004 | 5 |
| −1 | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015 | 2 |
| 0 (this device) | K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsSummary page 4…21 CFR 880.5725 Product Code: LZH Device Class: Class II Predicate Device(s): (K143263) Kangaroo™ Connect Enteral Feeding Pump and Connect Feeding Set Device Description: The… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 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. 2020, 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 PUGGLE® Enteral Feeding Pump and Feeding Set are 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 PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users
ranging from laypersons to physicians.
The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.
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/K200051 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200051: PUGGLE Enteral Feeding Pump and Feeding Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200051
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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