510(k) · Cleared

Recalled · Class II · 2017

Flex-Neck PD Catheter, Infant

K031351510(k) TraditionalCleared Sep 17, 2003141-day reviewClass II21 CFR 876.5630Recalls 3

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

Medigroup, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling

Cleared on Sep 17, 2003 as substantially equivalent to K970159 (Janin Group, Inc., 1997) after a 141-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled 3 times.

Decided: Sep 17, 2003
Review: 141 days
Class: Class II
Product code: FJS
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K970159 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970159 Flex-Neck PD CatheterJanin Group, Inc. · 1997 · Recalled
This deviceK031351 Flex-Neck PD Catheter, InfantMedigroup, Inc. · 2003
Descendant · cites it directly · 0 of its ownK070730 Flex-Neck Arc CatheterMedigroup, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K070730Flex-Neck Arc CatheterMedigroup, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970159	Flex-Neck PD Catheter	Janin Group, Inc.	1997	1
0 (this device)	K031351	Flex-Neck PD Catheter, Infant	Medigroup, Inc.	2003	—
+1	K070730	Flex-Neck Arc Catheter	Medigroup, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K031351, 1997–2007Source: 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 FJS? 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 FJS device

#1 K213602 Argyle Peritoneal Dialysis Cathetor and Kit…score 3.0 · 2 generations · no Class I recall

Get a 510(k) Report

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
*	K970159	Flex-Neck PD Catheter	Janin Group, Inc.	1997	1

Also cleared against K970159: 2 other devices →

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
K070730	Flex-Neck Arc Catheter	Medigroup, Inc.	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 20, 2017	Class II	Z-1144-2018	Mixed-up of materials/components	2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Sep 20, 2017	Class II	Z-1143-2018	Mixed-up of materials/components	2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Sep 20, 2017	Class II	Z-1145-2018	Mixed-up of materials/components	1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K070730 (Medigroup, Inc., 2007) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K970159.

How does its category compare?

All FJS devices

FJS Catheter, Peritoneal, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJS

1in 2022

2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJS

120in 2012

2007high 120 (2012)2026

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

Recalls per year · FJS

1in 2014

2007high 4 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FJS

140in 2025

2007high 619 (2023) · low 9 (2008)2025

MAUDE reports naming product code FJS, 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	2	—	0	12
2008	0	—	0	9
2009	0	—	0	75
2010	0	—	0	67
2011	0	—	4	58
2012	3	120	0	37
2013	1	—	0	84
2014	0	—	1	66
2015	0	—	0	61
2016	0	—	0	38
2017	0	—	0	75
2018	1	—	0	137
2019	0	—	0	53
2020	0	—	0	94
2021	0	—	0	78
2022	1	—	0	102
2023	0	—	0	619
2024	0	—	0	149
2025	0	—	0	140
2026	0	—	0	—

What is it indicated for?

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck catheters, the Flex-Neck Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031351: Flex-Neck PD Catheter, Infant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031351

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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