510(k) · Cleared

Cleared

Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P

K014297510(k) TraditionalCleared Jul 9, 2002190-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

Boston Scientific Corp · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jul 9, 2002 after a 190-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.

Decided: Jul 9, 2002
Review: 190 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 0

16 later devices descend from it, 4 citing it directly.

This deviceK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
Descendant · cites it directly · 6 of its ownK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
Descendant · cites it directly · 3 of its ownK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · Recalled
Descendant · 2 generations on · 2 of its ownK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
Descendant · cites it directly · 2 of its ownK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 16 · See all

K030855Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety KitBoston Scientific Corp · 2003 · cites it directly6descendants
K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 2009 · cites it directly3descendants
K031538Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · 2 generations on3descendants
K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014 · 2 generations on2descendants
K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K014297	Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button…	Boston Scientific Corp	2002	—
+1	K030855	Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety…	Boston Scientific Corp	2003	2
+1	K083685	Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285	Mri Manufacturing and Research, Inc.	2009	—
+2	K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit	Boston Scientific Corp	2003	21
+2	K130674	Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube	Xeridiem Medical Devices	2014	—
+1	K083684	Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX	Manufacturing & Research, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2006	1	0
2009	2	0
2013	1	0
2014	2	0
2015	2	0
2016	1	0
2017	1	0
2018	2	0
2019	1	0
2023	1	0

FIG. 1 — Lineage of K014297, 2002–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Recalls
*	—	Endovive Initial Placement Gastrostomy Kit Named without a submission number	—
*	—	Securi-T Initial Placement Gastrostomy Kit Named without a submission number	—
*	—	Endovive Low Profile Button Replacement Gastrostomy Tube Named without a submission number	—
*	—	Endovive Low Profile Initial Placement Gastrostomy Kit Named without a submission number	—

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K030855	Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit	Boston Scientific Corp	2003	6
K083685	Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285	Mri Manufacturing and Research, Inc.	2009	3
K083684	Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX	Manufacturing & Research, Inc.	2009	2
K161003	EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…	Boston Scientific Corporation	2016	1

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, K030855 (Boston Scientific Corp, 2003) has gone furthest, with 6 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

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

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

Recalls per year · KNT

13in 2025

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

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

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 Endovive Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means.

The Endovive Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014297 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014297

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026