510(k) · Decided

Decided

Flex-Neck Arc Catheter

K070730510(k) TraditionalDecided Jul 3, 2007110-day reviewClass II21 CFR 876.5630

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 Jul 3, 2007 as substantially equivalent to K862046 (Accurate Surgical Instruments Co., 1986) and 2 other predicates after a 110-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jul 3, 2007
Review: 110 days
Class: Class II
Product code: FJS
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K970159 (1997). 3 ancestors in all, the oldest K862046 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970159 Flex-Neck PD CatheterJanin Group, Inc. · 1997 · Recalled
1 generation backK031351 Flex-Neck PD Catheter, InfantMedigroup, Inc. · 2003 · Recalled
This deviceK070730 Flex-Neck Arc CatheterMedigroup, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970159	Flex-Neck PD Catheter	Janin Group, Inc.	1997	1
−1	K031351	Flex-Neck PD Catheter, Infant	Medigroup, Inc.	2003	3
0 (this device)	K070730	Flex-Neck Arc Catheter	Medigroup, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0

FIG. 1 — Lineage of K070730, 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? (3)

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
*	K862046	Swan-Neck Peritoneal Dialysis Catheters Summary page 1 …y. Class: II Predicate Devices 510(k) 862046 Swan-NeckTM PD Catheter issued June 19, 1986 510(k) 970159 Flex-Neck® PD Catheter issued Se…	Accurate Surgical Instruments Co.	1986	—
*	K970159	Flex-Neck PD Catheter Summary page 1 …Predicate Devices 510(k) 862046 Swan-NeckTM PD Catheter issued June 19, 1986 510(k) 970159 Flex-Neck® PD Catheter issued September 5, 1997 510(k) 031351 Flex-Neck® PD Catheter, Infan…	Janin Group, Inc.	1997	1
*	K031351	Flex-Neck PD Catheter, Infant Summary page 1 …ter issued June 19, 1986 510(k) 970159 Flex-Neck® PD Catheter issued September 5, 1997 510(k) 031351 Flex-Neck® PD Catheter, Infant, issued September 17, 2003 Product Description…	Medigroup, Inc.	2003	3

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
2 of the 3 ancestors have a recall of any class.

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. 2007, this device’s year, is highlighted.

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 a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC TM peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070730 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070730: Flex-Neck Arc Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070730

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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