510(k) · Cleared
Recalled · Class II · 2012Enteralite Infinity Enteral Feeding Pump
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 Jul 9, 2003 as substantially equivalent to K954735 (Zevex Intl., Inc., 1996) after an 86-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 9, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851539 (1985). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- 1 generation backK954735 EnteraliteZevex Intl., Inc. · 1996
- This deviceK031199 Enteralite Infinity Enteral Feeding PumpZevex Intl., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK232205 Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™…Vesco Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK131154 Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity…Zevex, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −2 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −1 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| 0 (this device) | K031199 | Enteralite Infinity Enteral Feeding Pump | Zevex Intl., Inc. | 2003 | — |
| +1 | K232205 | Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL… | Vesco Medical, LLC | 2023 | — |
| +1 | K131154 | Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag… | Zevex, Inc. | 2014 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 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.
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 |
|---|---|---|---|
| * | K954735 | EnteraliteSummary page 1…p Common name: Infusion pump, Enteral, External Classification: Class I1 Product Code: SOLZH, 880.5725 Substantial equivalence claimed to: K954735 - EnteraLite Enteral Feeding Pump - ZEVEX, Inc. Description: The EnteraLiteO Infinity'rM Enteral Feeding Pump as referred to as… | 1996 |
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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2012 | Class II | Z-0294-2013 | Component design/selection | MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in… |
| Oct 12, 2012 | Class II | Z-0764-2013 | Nonconforming Material/Component | The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line. |
| Dec 18, 2008 | Not classified | Z-2112-2009 | Software design (manufacturing process) | Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing. |
| Dec 18, 2008 | Not classified | Z-2113-2009 | Software design (manufacturing process) | Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232205 (Vesco Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K954735.
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 EnteraLiteO InfinityTMEnteral Feeding Pump is a rotary peristaltic pump designed to
deliver programmed doses of enteral nutrition solutions at selectable rates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031199: Enteralite Infinity Enteral Feeding Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031199
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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