510(k) · Cleared
ClearedHospira Enteral Feeding Set, Model 20640
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Sep 11, 2006 as substantially equivalent to K810996 (Abbott Laboratories, 1981) after a 110-day review. Its family tree reaches back 1 generation to 1981. 4 of the 13 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 110 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810996 (1981). 11 later devices descend from it, 2 citing it directly. 4 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK810996 Enternal Pump Set W/Integral ContainerAbbott Laboratories · 1981
- This deviceK061432 Hospira Enteral Feeding Set, Model 20640Hospira, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK223607 Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · cites it directly9descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on5descendants
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on2descendants
- K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · 2 generations on2descendants
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810996 | Enternal Pump Set W/Integral Container | Abbott Laboratories | 1981 | — |
| 0 (this device) | K061432 | Hospira Enteral Feeding Set, Model 20640 | Hospira, Inc. | 2006 | — |
| +1 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +2 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +3 | K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023 | Class I |
| +2 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
| +3 | K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 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.
4 devices in this family have a Class I recall. 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K810996 | Enternal Pump Set W/Integral ContainerSummary page 1…e The HOSPIRA™ Enteral Feeding Sets as described in this submission is substantially cquivalent w the primary predicate device Enteral Pump Set with Integral Container (K810996 & KOS2032) with vespect o the following: Stntares: 1) Both devices are mtended to temporarily huld and delives nuiritional fluds… | 1981 |
| Kept off the family tree | K052032 | Enteral Pump Set with Integral Container Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| Kept off the family tree | K850059 | FDA’s K850059 is DU Pont Gentamicin Assay Calibrator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1985 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K141789 (Hospira, Inc., 2015) has gone furthest, with 9 descendants of its own.
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 Hospira® Enteral Feeding Sets is intended to deliver, via gravity or a pump, liquid nutrition formulas to an enteral access device (a feeding tube).
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/K061432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061432: Hospira Enteral Feeding Set, Model 20640.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061432
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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