510(k) · Cleared
ClearedDevice Modification of Enteral Feeding Sets for Gravity and Pump Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zevex, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 2, 2001 as substantially equivalent to K954735 (Zevex Intl., Inc., 1996) and 1 other predicate after a 115-day review. Its family tree reaches back 2 generations to 1985. 14 later devices descend from it.
- Decided
- Nov 2, 2001
- Review
- 115 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851539 (1985). 4 ancestors in all. 14 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 deviceK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
- Descendant · 2 generations on · 8 of its ownK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
- Descendant · 4 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
- Descendant · cites it directly · 2 of its ownK142539 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral…Zevex, Inc. · 2015 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…Dynarex Corporation · 2009 · cites it directly10descendants
- K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc. · 2014 · 2 generations on8descendants
- K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · 3 generations on7descendants
- K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · 4 generations on2descendants
- K142539EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetZevex, Inc. · 2015 · cites it directly2descendants
View 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) | K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump Use | Zevex, Inc. | 2001 | — |
| +1 | K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding… | Dynarex Corporation | 2009 | — |
| +2 | K133077 | Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag… | Generica Medical International, Inc. | 2014 | — |
| +3 | K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015 | — |
| +4 | K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | 2017 | — |
| +1 | K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding… | Zevex, Inc. | 2015 | 1 |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 |
|---|---|---|---|
| * | K954735 | EnteraliteSummary page 1…ing Sets for Gravity and Pump Use Common Name: Enteral Feeding Sets for Gravity and Pump Use Classification Name: Tubes, Gastrointestinal (and Accessories) Predicates: K954735 Infusion pump, enteral, external (disposable sets were included as accessories) K 862489 Enteral Feeding Sets for Gravity and Pum… | 1996 |
| * | K862489 | Enteral Feeding Sets for Gravity and Pump UseSummary page 1…Use Classification Name: Tubes, Gastrointestinal (and Accessories) Predicates: K954735 Infusion pump, enteral, external (disposable sets were included as accessories) K 862489 Enteral Feeding Sets for Gravity and Pump Use The devices in this product family are used to dispense liquid nutrients (feeding… | 1986 |
What descends from it? (14)
See all 142 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 16 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082863 (Dynarex Corporation, 2009) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K954735.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a 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 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/K012147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012147: Device Modification of Enteral Feeding Sets for Gravity and Pump Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012147
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026