510(k) · Cleared
ClearedEnteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zevex, Inc. · LZH Pump, Infusion, Enteral
Cleared on Feb 12, 2014 as substantially equivalent to K031199 (Zevex Intl., Inc., 2003) after a 294-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Feb 12, 2014
- Review
- 294 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851539 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- 2 generations backK954735 EnteraliteZevex Intl., Inc. · 1996
- 1 generation backK031199 Enteralite Infinity Enteral Feeding PumpZevex Intl., Inc. · 2003 · Recalled
- This deviceK131154 Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity…Zevex, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −2 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| −1 | K031199 | Enteralite Infinity Enteral Feeding Pump | Zevex Intl., Inc. | 2003 | 4 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K031199 | Enteralite Infinity Enteral Feeding PumpSummary page 1…eral Feeding Pump Common name: Disposable Tubing sets Classification name: 21 CER 880.5725 Infusion pump Substantial equivalence claimed to: K031 199- EnteraLite Infinity Enteral Feeding Pump- ZEVEX, INC Description: The EnteraLite®)Infinity®& Enteral Feeding Pump as referre… | 2003 |
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 29 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K031199.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 EnteraLite Infinity Enteral 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/K131154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131154: Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131154
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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