510(k) · Cleared
ClearedEntri Flex Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 28, 1983 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 48 devices in its family, counting itself, has a Class I recall. 47 later devices descend from it.
- Decided
- Nov 28, 1983
- Review
- 45 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 3 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- This deviceK833621 Entri Flex Feeding TubeBiosearch Medical Products, Inc. · 1983
- Descendant · cites it directly · 43 of its ownK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- Descendant · 2 generations on · 40 of its ownK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- Descendant · 3 generations on · 35 of its ownK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- Descendant · 4 generations on · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 5 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe8 generations on · 2019
Most influential descendants
Showing 5 of 47 · See all- K973409Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998 · cites it directly43descendants
- K082654Enteral Only Extension SetRespironics, Inc. · 2008 · 2 generations on40descendants
- K100099Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010 · 3 generations on35descendants
- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · 4 generations on33descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833621 | Entri Flex Feeding Tube | Biosearch Medical Products, Inc. | 1983 | — |
| +1 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| +2 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| +3 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| +4 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +5 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 1 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (47)
See all 473 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 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K973409 (Davis & Geck, Inc., 1998) has gone furthest, with 43 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 | — |
https://510kreport.com/device/K833621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K833621: Entri Flex Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833621
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026