510(k) · Cleared
Recalled · 2010Nutrisafe Extension Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 29, 1999 after a 144-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 49 devices in its family, counting itself, has a Class I recall. 48 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 29, 1999
- Review
- 144 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 2
- Predicates
- 0
48 later devices descend from it, 2 citing it directly. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- This deviceK991918 Nutrisafe Extension TubeVygon Corp. · 1999
- Descendant · cites it directly · 42 of its ownK060944 Nutrisafe 2Vygon Corp. · 2006 · Recalled
- Descendant · cites it directly · 40 of its ownK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- Descendant · 2 generations on · 35 of its ownK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- Descendant · 3 generations on · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 4 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe7 generations on · 2019
Most influential descendants
Showing 5 of 48 · See all- K060944Nutrisafe 2Vygon Corp. · 2006 · cites it directly42descendants
- K082654Enteral Only Extension SetRespironics, Inc. · 2008 · cites it directly40descendants
- K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010 · 2 generations on35descendants
- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · 3 generations on33descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991918 | Nutrisafe Extension Tube | Vygon Corp. | 1999 | — |
| +1 | K060944 | Nutrisafe 2 | Vygon Corp. | 2006 | 3 |
| +1 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| +2 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| +3 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +4 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 1 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (48)
See all 482 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2010 | Not classified | Z-1204-2010 | Labeling Change Control | Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml. |
| Jan 29, 2010 | Not classified | Z-1203-2010 | Labeling Change Control | Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml. |
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.
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K060944 (Vygon Corp., 2006) has gone furthest, with 42 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 Nutrisafe Extension Tube is intended for use with the Nutrisafe Feeding Tube, which incorporates safety luer lock hub connectors, which eliminate the risk of I.V. administration through the feeding tube. The Nutrisafe Extension Tube will allow 150 cm of additional tubing for the clinician to utilize, where necessary.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991918: Nutrisafe Extension Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991918
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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