510(k) Report

510(k) · Cleared

Cleared

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

K191114510(k) TraditionalCleared Aug 9, 2019105-day reviewClass II21 CFR 870.1252

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

Avenu Medical · PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Cleared on Aug 9, 2019 as substantially equivalent to K183615 (Avenu Medical, Inc., 2019) after a 105-day review. Its family tree reaches back 3 generations to 2018.

Decided
Aug 9, 2019
Review
105 days
Class
Class II
Product code
PQK
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to DEN170004 (2018). No later device cites it as a predicate yet.

Reference device: DEN170004 · Ellipsys Vascular Access System · Avenu Medical, Inc. · 2018DEN170004 · Ellipsys Vascular Access System · Avenu Medical, Inc. · 2018K181725 · Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) · Avenu Medical, Inc. · 2018K183615 · Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle · Avenu Medical, Inc. · 2019201620182020
K183615 · Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle · Avenu Medical, Inc. · 2019K181725 · Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) · Avenu Medical, Inc. · 2018DEN170004 · Ellipsys Vascular Access System · Avenu Medical, Inc. · 20180
  1. Root · 3 generations backDEN170004 Ellipsys Vascular Access SystemAvenu Medical, Inc. · 2018
  2. 2 generations backK181725 Ellipsys Vascular Access System (Ellipsys System), (Power Controller…Avenu Medical, Inc. · 2018
  3. 1 generation backK183615 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical, Inc. · 2019
  4. This deviceK191114 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3DEN170004Ellipsys Vascular Access SystemAvenu Medical, Inc.2018—
−2K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No.…Avenu Medical, Inc.2018—
−1K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys…Avenu Medical, Inc.2019—
0 (this device)K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys…Avenu Medical2019—
FIG. 1 — Lineage of K191114, 2018–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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.

TypeNumberDeviceApplicantDecidedRecalls
*K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…
Summary page 4
…er: 21 CFR 870.1252 III. PREDICATE DEVICE Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1001, Model AMI-6005 and AMI-3000 510(k) Premarket Notification: K183615 Regulation Number: 21 CFR 870.1252 This predicate has not been subject to a recall. IV. DEVICE DESCRIPTION The device that is t…
Avenu Medical, Inc.2019—
†DEN170004Ellipsys Vascular Access SystemAvenu Medical, Inc.2018—

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 1 year and passes through 2 companies; a new generation was cleared every 4 months on median.
  • None of the 3 ancestors has a recall.

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

2018: 32019: 4
2007high 4 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQK

82in 2019

2019: 82 days median
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

2018: 32019: 512020: 612021: 742022: 772023: 712024: 782025: 44
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20183—03
2019482051
20200—061
20210—074
20220—077
20230—071
20240—078
20250—044
20260—0—

What is it indicated for?

The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Indications for use as stated in the FDA summary.

Recent decisions in PQK

The PQK category page

  • K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 20191 recall
  • K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. · 20191 recall
  • K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System…Avenu Medical, Inc. · 2019
  • K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle…Avenu Medical, Inc. · 2018
  • DEN170004Ellipsys Vascular Access SystemAvenu Medical, Inc. · 2018

https://510kreport.com/device/K191114 · printed Nov 5, 2026

Cite this page

510(k) Report. “K191114: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191114

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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