510(k) · Cleared

Recalled · Class II · 2014

WavelinQ Plus EndoAVF System

K192239510(k) TraditionalCleared Oct 17, 201959-day reviewClass II21 CFR 870.1252Recalls 1

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

C.R. Bard, Inc. · PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Cleared on Oct 17, 2019 as substantially equivalent to K182796 (C.R. Bard, Inc., 2019) after a 59-day review. Its family tree reaches back 2 generations to 2018. It has been recalled once.

Decided: Oct 17, 2019
Review: 59 days
Class: Class II
Product code: PQK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to DEN160006 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN160006 everlinQ endoAVF SystemTva Medical, Inc. · 2018
1 generation backK182796 WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. · 2019 · Recalled
This deviceK192239 WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN160006	everlinQ endoAVF System	Tva Medical, Inc.	2018	—
−1	K182796	WavelinQ 4F EndoAVF System	C.R. Bard, Inc.	2019	1
0 (this device)	K192239	WavelinQ Plus EndoAVF System	C.R. Bard, Inc.	2019	—

FIG. 1 — Lineage of K192239, 2018–2019Source: 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 PQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K182796	WavelinQ 4F EndoAVF System Summary page 4 …rdiovascular Regulation Number: 21 CFR 870.1252 Predicate Device: Device Trade Name: WavelinQ™ 4F EndoAVF System 510(k) Number: K182796 Common or Usual Name: Percutaneous catheter for creation of an arteriovenous fistula for…	C.R. Bard, Inc.	2019	1

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
Jun 13, 2014	Class II	Z-2085-2014	Software design	Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All PQK devices

PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PQK

4in 2019

2007high 4 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQK

82in 2019

2007high 82 (2019)2026

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

Recalls per year · PQK

No recall names PQK since 2007.

Adverse event reports per year · PQK

44in 2025

2007high 78 (2024) · low 0 (2007)2025

MAUDE reports naming product code PQK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	3	—	3
2019	4	82	51
2020	0	—	61
2021	0	—	74
2022	0	—	77
2023	0	—	71
2024	0	—	78
2025	0	—	44
2026	0	—	—

What is it indicated for?

The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K192239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192239: WavelinQ Plus EndoAVF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192239

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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