510(k) · Cleared
ClearedEnteralite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zevex Intl., Inc. · LZH Pump, Infusion, Enteral
Cleared on Apr 15, 1996 as substantially equivalent to K913413 (Sherwood Medical Co., 1991) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1985. 19 later devices descend from it.
- Decided
- Apr 15, 1996
- Review
- 182 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851539 (1985). 2 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- This deviceK954735 EnteraliteZevex Intl., Inc. · 1996
- Descendant · cites it directly · 14 of its ownK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- Descendant · 2 generations on · 10 of its ownK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
- Descendant · 3 generations on · 8 of its ownK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
- Descendant · 4 generations on · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
- Descendant · 5 generations on · 2 of its ownK163586 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit…Trovrx, Inc. Dba Trovita Health Science · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001 · cites it directly14descendants
- K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…Dynarex Corporation · 2009 · 2 generations on10descendants
- K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc. · 2014 · 3 generations on8descendants
- K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · 4 generations on7descendants
- K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| 0 (this device) | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| +1 | K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump Use | Zevex, Inc. | 2001 | — |
| +2 | K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding… | Dynarex Corporation | 2009 | — |
| +3 | K133077 | Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag… | Generica Medical International, Inc. | 2014 | — |
| +4 | K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015 | — |
| +5 | K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K913413 | Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger BaseSummary page 1…54 ZEVEX, Incorporated believes the Enteralite enteral feeding pump is substantially equivalent to the Kangaroo PET device reviewed by FDA under Document Control number K913413 and its introduction into interstate commerce raises no new questions of safety or efficacy. The predicate device for the dispos… | 1991 |
| * | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloSummary page 1…rated believes the Enteralite disposable feeding set is substantially equivalent to the Kangaroo PET disposable feeding set reviewed by FDA under document control number K851539 and its introduction into interstate commerce raises no new questions of safety or efficacy. ZEVX, Inc., Summary… | 1985 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K012147 (Zevex, Inc., 2001) has gone furthest, with 14 descendants of its own.
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?
The EnteraLite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.
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/K954735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954735: Enteralite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954735
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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