510(k) Report

510(k) · Cleared

Cleared

Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger Base

K913413510(k) TraditionalCleared Nov 29, 1991121-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sherwood Medical Co. · LZH Pump, Infusion, Enteral

Cleared on Nov 29, 1991 after a 121-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it.

Decided
Nov 29, 1991
Review
121 days
Class
Class II
Product code
LZH
Recalls
None
Predicates
0

20 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2001: 1 descendant cleared2006: 1 descendant cleared2003: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2023: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2024: 3 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK913413 Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger BaseSherwood Medical Co. · 1991
  2. Descendant · cites it directly · 19 of its ownK954735 EnteraliteZevex Intl., Inc. · 1996
  3. Descendant · 2 generations on · 14 of its ownK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
  4. Descendant · 3 generations on · 10 of its ownK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
  5. Descendant · 4 generations on · 8 of its ownK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
  6. Descendant · 5 generations on · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1996: 12001: 12003: 12006: 12009: 12012: 12014: 22015: 22017: 12018: 12021: 22022: 12023: 22024: 3
1996high 3 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 20 · See all
  • K954735EnteraliteZevex Intl., Inc. · 1996 · cites it directly19descendants
  • K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001 · 2 generations on14descendants
  • K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…Dynarex Corporation · 2009 · 3 generations on10descendants
  • K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc. · 2014 · 4 generations on8descendants
  • K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · 5 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913413Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger BaseSherwood Medical Co.1991—
+1K954735EnteraliteZevex Intl., Inc.1996—
+2K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc.2001—
+3K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding…Dynarex Corporation2009—
+4K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag…Generica Medical International, Inc.2014—
+5K150286Medline Enteral Feeding SetsMedline Industries, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200310
200610
200910
201210
201420
201520
201710
201810
202120
202210
202320
202430
FIG. 1 — Lineage of K913413, 1991–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253558 Luminoah FLOW™ Enteral Nutrition Systemscore 13.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (20)

See all 20

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K954735EnteraliteZevex Intl., Inc.199619

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?

  • Of its descendants, K954735 (Zevex Intl., Inc., 1996) has gone furthest, with 19 descendants of its own.

How does its category compare?

All LZH devices

LZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZH

1in 2023

2012: 12014: 22015: 12016: 12020: 12022: 22023: 12026 (partial year): 1
2007high 2 (2014) · low 0 (2007)2026

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

2007: 22008: 32009: 12011: 12012: 22020: 2
2007high 3 (2008) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZH

376in 2025

2007: 1,1502008: 8582009: 1242010: 2202011: 2742012: 3982013: 3492014: 1192015: 832016: 1,2482017: 2,6202018: 1,6522019: 7422020: 1,4602021: 1,2182022: 5262023: 2842024: 3192025: 376
2007high 2,620 (2017) · low 83 (2015)2025

MAUDE reports naming product code LZH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—21,150
20080—3858
20090—1124
20100—0220
20110—1274
20121—2398
20130—0349
20142—0119
20151—083
20161—01,248
20170—02,620
20180—01,652
20190—0742
20201—21,460
20210—01,218
20222—0526
20231—0284
20240—0319
20250—0376
20261—0—
Cite this page

510(k) Report. “K913413: Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913413

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026