510(k) · Decided

Recalled · Class II · 2026

EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector

K150679510(k) TraditionalDecided May 29, 201573-day reviewClass II21 CFR 876.5980Recalls 3

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

Boston Scientific Corp · PIF Gastrointestinal Tubes With Enteral Specific Connectors

Cleared on May 29, 2015 as substantially equivalent to K031538 (Boston Scientific Corp, 2003) after a 73-day review. Its family tree reaches back 3 generations to 2002. It has been recalled 3 times.

Decided: May 29, 2015
Review: 73 days
Class: Class II
Product code: PIF
Recalls: 3
Predicates: 1

Its longest line of descent runs back 3 generations to K014297 (2002). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
2 generations backK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
1 generation backK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003 · Recalled
This deviceK150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector…Boston Scientific Corp · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K014297	Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button…	Boston Scientific Corp	2002	—
−2	K030855	Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety…	Boston Scientific Corp	2003	2
−1	K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit	Boston Scientific Corp	2003	21
0 (this device)	K150679	EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive…	Boston Scientific Corp	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K150679, 2002–2015Source: 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 PIF? 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 PIF device

#1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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? (1)

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
*	K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit Summary page 5 …acement Standard PEG Kit, EndoVive™ Initial Placement Safety PEG Kit Manufacturer and Clearance Number: Boston Scientific Corporation, K031538 Classification Name: Gastrointestinal tube and accessories Product Code: 78 KNT Device Class a…	Boston Scientific Corp	2003	21

Also cleared against K031538: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 10, 2026	Class II	Z-1551-2026	Process control	Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed…
Feb 20, 2024	Class II	Z-1514-2024	Process design	Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events…
Feb 20, 2024	Class II	Z-1513-2024	Process design	Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 9 months on median.
2 of the 4 ancestors have a recall of any class.
1 other device also cites its predicate K031538.

How does its category compare?

All PIF devices

PIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · PIF

2in 2025

2007high 9 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIF

242in 2023

2007high 267 (2016) · low 119 (2014)2026

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

Recalls per year · PIF

1in 2024

2007high 106 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PIF

83in 2025

2007high 110 (2024) · low 0 (2007)2025

MAUDE reports naming product code PIF, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	3	119	0	0
2015	9	143	106	12
2016	3	267	0	45
2017	5	174	0	17
2018	2	—	0	17
2019	7	135	0	28
2020	4	165	0	70
2021	4	242	0	89
2022	4	167	0	77
2023	4	242	0	96
2024	2	—	1	110
2025	2	—	0	83
2026	3	239	0	—

What is it indicated for?

The Initial Placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150679 · printed Nov 3, 2026

Cite this page

510(k) Report. “K150679: EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150679

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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