510(k) · Decided

Recalled · 2008

Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit

K030855510(k) SpecialDecided Apr 17, 200330-day reviewClass II21 CFR 876.5980Recalls 2

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 Apr 17, 2003 as substantially equivalent to K014297 (Boston Scientific Corp, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it. It has been recalled 2 times.

Decided: Apr 17, 2003
Review: 30 days
Class: Class II
Product code: KNT
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K014297 (2002). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
This deviceK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003
Descendant · cites it directly · 3 of its ownK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · Recalled
Descendant · cites it directly · 1 of its ownK133087 Abbvie PegAbbVie, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK061021 Entake Standard and Safety Peg SystemConmedcorp · 2006 · Recalled
Descendant · 3 generations on · 0 of its ownK182248 Aspire Venting TubeAspire Bariatrics, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector…Boston Scientific Corp · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003high 2 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all

K031538Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · cites it directly3descendants
K133087Abbvie PegAbbVie, Inc. · 2014 · cites it directly1descendant
K061021Entake Standard and Safety Peg SystemConmedcorp · 2006 · 2 generations on1descendant
K182248Aspire Venting TubeAspire Bariatrics, Inc. · 2018 · 3 generations on0descendants
K150679EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial…Boston Scientific Corp · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K014297	Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button…	Boston Scientific Corp	2002	—
0 (this device)	K030855	Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety…	Boston Scientific Corp	2003	—
+1	K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit	Boston Scientific Corp	2003	21
+1	K133087	Abbvie Peg	AbbVie, Inc.	2014	—
+2	K061021	Entake Standard and Safety Peg System	Conmedcorp	2006	28
+3	K182248	Aspire Venting Tube	Aspire Bariatrics, Inc.	2018	—
+2	K150679	EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive…	Boston Scientific Corp	2015	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2014	1	0
2015	2	0
2018	1	0

FIG. 1 — Lineage of K030855, 2002–2018Source: 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? (2)

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	Applicant	Decided	Recalls
*	K014297	Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement…	Boston Scientific Corp	2002	—
*	K020120	Endovive Initial Placement Direct Pej Kit, Endovive Standard Profile Balloon…	Boston Scientific Corp	2002	—

Also cleared against K014297: 3 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit	Boston Scientific Corp	2003	3
K133087	Abbvie Peg	AbbVie, Inc.	2014	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 17, 2008	Not classified	Z-2236-2008	Labeling mix-ups	Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
Jun 17, 2008	Not classified	Z-2237-2008	Labeling mix-ups	Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K031538 (Boston Scientific Corp, 2003) has gone furthest, with 3 descendants of its own.
3 other devices also cite its predicate K014297.

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?

EndoViveTMInitial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. The EndoViveTMInitial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The EndoViveThlInitial Placement PEG Safety Kit is indicated for…

Read the full statement (104 words)

EndoViveTMInitial Placement PEG Kit is indicated for enteral

nutrition directly into the stomach in both pediatric and adult patients

who are unable to consume nutrition by conventional means.

The EndoViveTMInitial Placement Direct PEJ Kit is indicated for

nutritional support and decompression directly into the jejunum when

feeding via the upper gastrointestinal tract is contraindicated.

The EndoViveThlInitial Placement PEG Safety Kit is indicated for

providing nutrition directly into the stomach in patients who are

unable to consume nutrition by conventional means. The safety

components of the kit are designed to reduce the potential for

inadvertent sharps injury to medical personnel during and after tfie

procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030855 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030855: Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030855

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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