510(k) · Cleared

Cleared

BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube

K142075510(k) TraditionalCleared Jan 8, 2015161-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

Xeridiem (Formerly Mri) · PIF Gastrointestinal Tubes With Enteral Specific Connectors

Cleared on Jan 8, 2015 as substantially equivalent to K885339 (Superior Healthcare Group, Inc., 1989) after a 161-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Jan 8, 2015
Review: 161 days
Class: Class II
Product code: PIF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K885339 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK885339 Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitSuperior Healthcare Group, Inc. · 1989
This deviceK142075 BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding…Xeridiem (Formerly Mri) · 2015
Descendant · cites it directly · 0 of its ownK171347 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit…Xeridiem Medical Devices · 2017

Most influential descendants

Showing 1 of 1 · See all

K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit…Xeridiem Medical Devices · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K885339	Flow Thru 16,18,20,22 FR Replace. Gastro Tube Kit	Superior Healthcare Group, Inc.	1989	—
0 (this device)	K142075	BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube	Xeridiem (Formerly Mri)	2015	—
+1	K171347	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection…	Xeridiem Medical Devices	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K142075, 1989–2017Source: 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
*	K885339	Flow Thru 16,18,20,22 FR Replace. Gastro Tube Kit Summary page 4 …FR 876.5980, Product Code KNT] Classification Panel: Gastroenterology/Urology Class: Class II 510(k) Number: K885339 Device Description The Gastrostomy Feeding Tube (G-Tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tr…	Superior Healthcare Group, Inc.	1989	—

Also cleared against K885339: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K171347	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit…	Xeridiem Medical Devices	2017	0

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?

Its one ancestor has no recall.
Of its descendants, K171347 (Xeridiem Medical Devices, 2017) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K885339.

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 G-Tube is indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142075 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142075: BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142075

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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