510(k) Report

510(k) · Cleared

Cleared

Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set

K082710510(k) TraditionalCleared Jan 23, 2009129-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

Neochild, LLC · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jan 23, 2009 as substantially equivalent to K052903 (Promedic, Inc., 2005) and 5 other predicates after a 129-day review. Its family tree reaches back 5 generations to 1981. 4 later devices descend from it.

Decided
Jan 23, 2009
Review
129 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K810156 (1981). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1986: 1 other ancestor2010: 2 descendants cleared2017: 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. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K072756 · Non-IV Adapter for Infant NG Tube · Promedic, Inc. · 2007K052903 · Pediatric Feeding Tube · Promedic, Inc. · 2005K020005 · Infant Feeding Tubes · Promedic, Inc. · 2002K971354 · Knott NG Tube · Michael M. Knott, M.D. · 1997K810156 · Argyle Salem Sump Tube · Sherwood Medical Co. · 1981 · recalled−50
  1. Root · 5 generations backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
  2. 4 generations backK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
  3. 3 generations backK020005 Infant Feeding TubesPromedic, Inc. · 2002
  4. 2 generations backK052903 Pediatric Feeding TubePromedic, Inc. · 2005
  5. 1 generation backK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
  6. This deviceK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
  7. Descendant · cites it directly · 2 of its ownK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
  8. Descendant · 2 generations on · 0 of its ownK162340 Stomach TubeWell Lead Medical Co., Ltd. · 2017
  9. Descendant · 2 generations on · 0 of its ownK112863 Enteral Administration Set with Solution Container, Enteral…Acta Medical, LLC · 2012
  10. Descendant · cites it directly · 0 of its ownK100700 Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc. · 2010 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010 · cites it directly2descendants
  • K162340Stomach TubeWell Lead Medical Co., Ltd. · 2017 · 2 generations on0descendants
  • K112863Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral…Acta Medical, LLC · 2012 · 2 generations on0descendants
  • K100700Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K810156Argyle Salem Sump TubeSherwood Medical Co.19813
−4K971354Knott NG TubeMichael M. Knott, M.D.1997—
−3K020005Infant Feeding TubesPromedic, Inc.2002—
−2K052903Pediatric Feeding TubePromedic, Inc.2005—
−1K072756Non-IV Adapter for Infant NG TubePromedic, Inc.2007—
0 (this device)K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC2009—
+1K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid2010—
+2K162340Stomach TubeWell Lead Medical Co., Ltd.2017—
+2K112863Enteral Administration Set with Solution Container, Enteral Administration…Acta Medical, LLC2012—
+1K100700Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc.20106

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199410
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201210
201710
FIG. 1 — Lineage of K082710, 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K052903Pediatric Feeding Tube
Summary page 1
…/OG Tube Classification Name Tubes, Gastrointestinal (and Accessories) Predicate Devices NeoChild - Infant Feeding Tubes - K052903 NeoChild - Infant feeding Tube with non-IV…
Promedic, Inc.2005—
*K072756Non-IV Adapter for Infant NG Tube
Summary page 1
…t Feeding Tubes - K052903 NeoChild - Infant feeding Tube with non-IV connector - K072756 Klein Baker (Utah) - K945012 and K861090 - NutnCath Silicone…
Promedic, Inc.2007—
*K945012Catco Nutritional Catheter
Summary page 1
…Child - Infant feeding Tube with non-IV connector - K072756 Klein Baker (Utah) - K945012 and K861090 - NutnCath Silicone Feeding Tube and enteral feeding tube extension se…
Catco Medical, Inc.1995—
*K861090Nutri-Cath - Feeding Tube
Summary page 1
…nt feeding Tube with non-IV connector - K072756 Klein Baker (Utah) - K945012 and K861090 - NutnCath Silicone Feeding Tube and enteral feeding tube extension set…
Gesco Intl., Inc.1986—
*K925854Vygon - Enteral Feeding Tube - Polyurethane
Summary page 1
…0 - NutnCath Silicone Feeding Tube and enteral feeding tube extension set Vygon - K925854 - NutriSafe Polyurethane Feeding Tube NeoChild - K003854 Intravascular Admuistration Sets…
Vygon Corp.1994—
*K003854Intravascular Administration Set
Summary page 1
…ding tube extension set Vygon - K925854 - NutriSafe Polyurethane Feeding Tube NeoChild - K003854 Intravascular Admuistration Sets Device Description The proposed modification to Infant Feeding Tube and accessories is to add a…
Infusion Devices, Inc.2001—

Also cleared against K052903: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid20102
K100700Med-RX Pediatric Feeding Tubes and AccessoriesBenlan, Inc.20100

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 28 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K092628 (Alan Reid, 2010) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K052903.

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. 2009, 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 Infant Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastnc or orogastric placement Limted to <30 day placement Not intended for transpylonc placement

There are accessory extension sets which are used with the Feeding tubes

The Feeding tubes are available in different materials - PVC, Silicone or Polyurethane

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K082710: Safechild Enteral Feeding Tube and Accessories and Feeding Tube 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/K082710

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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