510(k) · Cleared
ClearedInfant Feeding Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedic, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 16, 2002 as substantially equivalent to K925854 (Vygon Corp., 1994) and 2 other predicates after a 195-day review. Its family tree reaches back 2 generations to 1981. 7 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 195 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810156 (1981). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
- 1 generation backK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
- This deviceK020005 Infant Feeding TubesPromedic, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- Descendant · cites it directly · 2 of its ownK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
- Descendant · 2 generations on · 0 of its ownK162340 Stomach TubeWell Lead Medical Co., Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052903Pediatric Feeding TubePromedic, Inc. · 2005 · cites it directly6descendants
- K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007 · 2 generations on5descendants
- K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC · 2009 · 2 generations on4descendants
- K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010 · cites it directly2descendants
- K162340Stomach TubeWell Lead Medical Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810156 | Argyle Salem Sump Tube | Sherwood Medical Co. | 1981 | 3 |
| −1 | K971354 | Knott NG Tube | Michael M. Knott, M.D. | 1997 | — |
| 0 (this device) | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| +1 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| +2 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| +2 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| +1 | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension Set | Alan Reid | 2010 | — |
| +2 | K162340 | Stomach Tube | Well Lead Medical Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925854 | Vygon - Enteral Feeding Tube - PolyurethaneSummary page 1…Feeding Tube Classification Name: Tubes, Gastrointestinal (and Accessories) Predicate Devices : Vygon - Infant Feeding Tubes - K925854 Klein-Baker - Neo-Care Feeding Tube - K86 1090 Kn… | 1994 |
| * | K861090 | Nutri-Cath - Feeding TubeSummary page 1…ccessories) Predicate Devices : Vygon - Infant Feeding Tubes - K925854 Klein-Baker - Neo-Care Feeding Tube - K86 1090 Knott Gastric tube - K971354 [Device Description: The Infant Feeding Tube is a small… | 1986 |
| * | K971354 | Knott NG TubeSummary page 1…eding Tubes - K925854 Klein-Baker - Neo-Care Feeding Tube - K86 1090 Knott Gastric tube - K971354 [Device Description: The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14… | 1997 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052903 (Promedic, Inc., 2005) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K925854.
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 Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30-day placement. Not intended for transpyloric placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020005: Infant Feeding Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020005
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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