510(k) · Cleared
Recalled · Class II · 2015EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zevex, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jan 8, 2015 as substantially equivalent to K012147 (Zevex, Inc., 2001) after a 121-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2015
- Review
- 121 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851539 (1985). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- This deviceK142539 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral…Zevex, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK240052 Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK210854 Enteral Feeding SetKb Medical (Group), Inc. · 2021
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 |
|---|---|---|---|---|---|
| −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 | K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump Use | Zevex, Inc. | 2001 | — |
| 0 (this device) | K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding… | Zevex, Inc. | 2015 | — |
| +1 | K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | 2024 | — |
| +1 | K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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 |
|---|---|---|---|
| * | K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump UseSummary page 4…ct Code: PIO Device Class: Class II Classification Panel: Gastroenterology/Urology 4. Legally Marketed Predicate Device(s) K012147, Zevex, Inc., Enteral Feeding Sets for Gravity and Pump Use 5. Device Description These enteral feeding sets are designed… | 2001 |
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 20, 2015 | Class II | Z-0415-2016 | Unknown/Undetermined by firm | Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K240052 (Beijing L&Z Medical Technology Development Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012147.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient’s feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142539: EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding 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/K142539
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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