510(k) · Cleared
ClearedMedline Enteral Feeding Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Apr 27, 2015 as substantially equivalent to K133077 (Generica Medical International, Inc., 2014) after an 81-day review. Its family tree reaches back 5 generations to 1985. 7 later devices descend from it.
- Decided
- Apr 27, 2015
- Review
- 81 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K851539 (1985). 7 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- 4 generations backK954735 EnteraliteZevex Intl., Inc. · 1996
- 3 generations backK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- 2 generations backK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
- 1 generation backK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
- This deviceK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK163586 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit…Trovrx, Inc. Dba Trovita Health Science · 2017
- Descendant · cites it directly · 1 of its ownK222678 Mobility+ Enteral Feeding SystemRockfield Medical · 2022
- Descendant · 2 generations on · 1 of its ownK210971 EnteraLoc FlowVonco Products · 2021
- Descendant · cites it directly · 1 of its ownK181276 CONOD Enteral Feeding SetsConod Medical Co., Limited · 2018
- Descendant · 2 generations on · 0 of its ownK240039 Enteral Feeding SetsHangzhou Primecare Medical Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · cites it directly2descendants
- K222678Mobility+ Enteral Feeding SystemRockfield Medical · 2022 · cites it directly1descendant
- K210971EnteraLoc FlowVonco Products · 2021 · 2 generations on1descendant
- K181276CONOD Enteral Feeding SetsConod Medical Co., Limited · 2018 · cites it directly1descendant
- K240039Enteral Feeding SetsHangzhou Primecare Medical Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −4 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| −3 | 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 | — |
| −1 | K133077 | Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag… | Generica Medical International, Inc. | 2014 | — |
| 0 (this device) | K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015 | — |
| +1 | K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | 2017 | — |
| +1 | K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022 | — |
| +2 | K210971 | EnteraLoc Flow | Vonco Products | 2021 | — |
| +1 | K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | 2018 | — |
| +2 | K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K133077 | Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetSummary page 4…II Classification Regulation: 21 CFR 876.5980 Classification Panel: Gastroenterology and Urology PREDICATE DEVICE Generica Medical International Enteral Feeding Sets (K133077)… | 2014 |
What descends from it? (7)
3 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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K163586 (Trovrx, Inc. Dba Trovita Health Science, 2017) has gone furthest, with 2 descendants of its own.
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?
Medline Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient’s feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.
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/K150286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150286: Medline Enteral Feeding Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150286
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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