510(k) · Cleared
ClearedGenerica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Generica Medical International, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 28, 2014 as substantially equivalent to K082863 (Dynarex Corporation, 2009) after a 301-day review. Its family tree reaches back 4 generations to 1985. 8 later devices descend from it.
- Decided
- Jul 28, 2014
- Review
- 301 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K851539 (1985). 6 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- 3 generations backK954735 EnteraliteZevex Intl., Inc. · 1996
- 2 generations backK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- 1 generation backK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
- This deviceK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
- Descendant · 2 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 · 2 generations on · 1 of its ownK222678 Mobility+ Enteral Feeding SystemRockfield Medical · 2022
- Descendant · 3 generations on · 1 of its ownK210971 EnteraLoc FlowVonco Products · 2021
- Descendant · 2 generations on · 1 of its ownK181276 CONOD Enteral Feeding SetsConod Medical Co., Limited · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · cites it directly7descendants
- K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · 2 generations on2descendants
- K222678Mobility+ Enteral Feeding SystemRockfield Medical · 2022 · 2 generations on1descendant
- K210971EnteraLoc FlowVonco Products · 2021 · 3 generations on1descendant
- K181276CONOD Enteral Feeding SetsConod Medical Co., Limited · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −3 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K133077 | Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag… | Generica Medical International, Inc. | 2014 | — |
| +1 | K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015 | — |
| +2 | K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | 2017 | — |
| +2 | K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022 | — |
| +3 | K210971 | EnteraLoc Flow | Vonco Products | 2021 | — |
| +2 | K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | 2018 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…Summary page 1…r Gravity & Pump Use Manufacturer: Dynarex Reference: K082863 K 133077… | 2009 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150286 | Medline Enteral Feeding Sets | 2015 | 7 |
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 5 companies; a new generation was cleared every 7.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150286 (Medline Industries, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K082863.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Enteral Feeding Sets are intended to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients 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 as stated in the FDA summary.
https://510kreport.com/device/K133077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133077: Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133077
Report an extraction error
Are you the manufacturer?
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