510(k) Report

510(k) · Cleared

Cleared

Mri's All Silicone Gastrostomy Tube

K951489510(k) TraditionalCleared Jun 7, 199568-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

Manufacturing & Research, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jun 7, 1995 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided
Jun 7, 1995
Review
68 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2009: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951489 Mri's All Silicone Gastrostomy TubeManufacturing & Research, Inc. · 1995
  2. Descendant · cites it directly · 7 of its ownK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
  3. Descendant · 2 generations on · 3 of its ownK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
  4. Descendant · 3 generations on · 2 of its ownK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
  5. Descendant · 2 generations on · 2 of its ownK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009
  6. Descendant · 4 generations on · 1 of its ownK180708 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1996: 12009: 22013: 12014: 12017: 12018: 12023: 1
1996high 2 (2009) · low 0 (1997)2026

Most influential descendants

Showing 5 of 8 · See all
  • K962375Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996 · cites it directly7descendants
  • K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 2009 · 2 generations on3descendants
  • K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014 · 3 generations on2descendants
  • K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009 · 2 generations on2descendants
  • K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951489Mri's All Silicone Gastrostomy TubeManufacturing & Research, Inc.1995—
+1K962375Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp1996—
+2K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc.2009—
+3K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices2014—
+2K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc.2009—
+4K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200920
201310
201410
201710
201810
202310
FIG. 1 — Lineage of K951489, 1995–2023Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962375Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp19967

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?

  • Of its descendants, K962375 (Boston Scientific Corp, 1996) has gone furthest, with 7 descendants of its own.

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.

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—

More from Manufacturing & Research, Inc.

2 FDA decisions under this applicant name. See the company

  • K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009

Recent decisions in KNT

The KNT category page

  • K262038danumed StomaMeterDanumed Medizintechnik GmbH · 2026
  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025

https://510kreport.com/device/K951489 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951489: Mri's All Silicone Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951489

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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