510(k) Report

510(k) · Cleared

Cleared

Enteral Feeding Tube and Accessories, Feeding Tube Extension Set

K092628510(k) TraditionalCleared May 20, 2010266-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alan Reid · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on May 20, 2010 as substantially equivalent to K020005 (Promedic, Inc., 2002) and 2 other predicates after a 266-day review. Its family tree reaches back 6 generations to 1981. 2 later devices descend from it.

Decided
May 20, 2010
Review
266 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K810156 (1981). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1982: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1986: 1 other ancestor2017: 1 descendant cleared2012: 1 descendant clearedK810156 · Argyle Salem Sump Tube · Sherwood Medical Co. · 1981 · recalledK971354 · Knott NG Tube · Michael M. Knott, M.D. · 1997K020005 · Infant Feeding Tubes · Promedic, Inc. · 2002K052903 · Pediatric Feeding Tube · Promedic, Inc. · 2005K072756 · Non-IV Adapter for Infant NG Tube · Promedic, Inc. · 2007K082710 · Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set · Neochild, LLC · 200919801990200020102020
  1. Root · 6 generations backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
  2. 5 generations backK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
  3. 4 generations backK020005 Infant Feeding TubesPromedic, Inc. · 2002
  4. 3 generations backK052903 Pediatric Feeding TubePromedic, Inc. · 2005
  5. 2 generations backK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
  6. 1 generation backK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
  7. This deviceK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
  8. Descendant · cites it directly · 0 of its ownK162340 Stomach TubeWell Lead Medical Co., Ltd. · 2017
  9. Descendant · cites it directly · 0 of its ownK112863 Enteral Administration Set with Solution Container, Enteral…Acta Medical, LLC · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K162340Stomach TubeWell Lead Medical Co., Ltd. · 2017 · cites it directly0descendants
  • K112863Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral…Acta Medical, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K810156Argyle Salem Sump TubeSherwood Medical Co.19813
−5K971354Knott NG TubeMichael M. Knott, M.D.1997—
−4K020005Infant Feeding TubesPromedic, Inc.2002—
−3K052903Pediatric Feeding TubePromedic, Inc.2005—
−2K072756Non-IV Adapter for Infant NG TubePromedic, Inc.2007—
−1K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC2009—
0 (this device)K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid2010—
+1K162340Stomach TubeWell Lead Medical Co., Ltd.2017—
+1K112863Enteral Administration Set with Solution Container, Enteral Administration…Acta Medical, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198610
199410
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201710
FIG. 1 — Lineage of K092628, 1981–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K020005Infant Feeding Tubes
Summary page 1
…Feeding Tube or NO /00 Tube Classification Name: Tubes, Gastrointestinal (and Accessories) Predicate Devices: NeoDevices - K020005 - Infant Feeding Tubes NeoChild - K082710 - Infant Feeding Tube…
Promedic, Inc.2002—
*K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set
Summary page 1
…astrointestinal (and Accessories) Predicate Devices: NeoDevices - K020005 - Infant Feeding Tubes NeoChild - K082710 - Infant Feeding Tube Argyle / Kendall - K820442 Feeding Tube Device Description: The pr…
Neochild, LLC2009—
*K820442Argyle Indwell Feeding Tube
Summary page 1
…020005 - Infant Feeding Tubes NeoChild - K082710 - Infant Feeding Tube Argyle / Kendall - K820442 Feeding Tube Device Description: The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add addi…
Sherwood Medical Co.19822

Also cleared against K020005: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162340Stomach TubeWell Lead Medical Co., Ltd.20170
K112863Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral…Acta Medical, LLC20120

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 29 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K162340 (Well Lead Medical Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K020005.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

What is it indicated for?

The Pediatric Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpyloric placement.

The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K092628: Enteral Feeding Tube and Accessories, Feeding Tube Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092628

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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