510(k) · Cleared
ClearedEnteral Only Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 25, 2008 as substantially equivalent to K991918 (Vygon Corp., 1999) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1980. 1 of the 47 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it.
- Decided
- Nov 25, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801558 (1980). 6 ancestors in all. 40 later devices descend from it, 2 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 1 generation backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- This deviceK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- Descendant · cites it directly · 35 of its ownK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- Descendant · 2 generations on · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 3 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- Descendant · 4 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- Descendant · 5 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe6 generations on · 2019
Most influential descendants
Showing 5 of 40 · See all- K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010 · cites it directly35descendants
- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · 2 generations on33descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 3 generations on31descendants
- K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 4 generations on30descendants
- K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −1 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| 0 (this device) | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| +1 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| +2 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +3 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| +4 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| +5 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K991918 | Nutrisafe Extension TubeSummary page 1…tion Panel Gastroenterology/I Urology Product Code KNT Predicate Devices Vygon Nutrisafe® Extension Tube (K991 918) Kangaroo Enteral Feeding Extension Set (K973409) Intended Use/indications for Use… | 1999 |
| * | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe PumpsSummary page 1…Predicate Devices Vygon Nutrisafe® Extension Tube (K991 918) Kangaroo Enteral Feeding Extension Set (K973409) Intended Use/indications for Use The Enteral Only Extension Set is intended for use as an extension set for nasogastric… | 1998 |
What descends from it? (40)
See all 402 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)
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.
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K100099 (Philips Children'S Medical Ventures, 2010) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K991918.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Only Extension Set is intended for use as an extension set for
nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety
connectors which reduce the risk of accidental connection of an L.V. system to
the enteral system, or the enteral system to an L.V. system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082654: Enteral Only Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082654
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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