510(k) · Cleared
ClearedEllipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avenu Medical, Inc. · PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Cleared on Jan 25, 2019 as substantially equivalent to K181725 (Avenu Medical, Inc., 2018) after a 30-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Jan 25, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- PQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170004 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN170004 Ellipsys Vascular Access SystemAvenu Medical, Inc. · 2018
- 1 generation backK181725 Ellipsys Vascular Access System (Ellipsys System), (Power Controller…Avenu Medical, Inc. · 2018
- This deviceK183615 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191114 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical · 2019
Most influential descendants
Showing 1 of 1 · See all- K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…Avenu Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | 2018 | — |
| −1 | K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No.… | Avenu Medical, Inc. | 2018 | — |
| 0 (this device) | K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys… | Avenu Medical, Inc. | 2019 | — |
| +1 | K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys… | Avenu Medical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001…Summary page 4…21 CFR 870.1252 III. PREDICATE DEVICE Name of Device: Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1001, Model AMI-6005 510(k) Number: K181725 Regulation Number: 21 CFR 870.1252 This predicate has not been subject to a recall. IV. DEVICE DESCRIPTION The… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular… | 2019 | 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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191114 (Avenu Medical, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PQK devicesPQK 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
2026 to Oct 25, outlined.
Median 510(k) review, days · PQK
82in 2019
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
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 | 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 3 |
| 2019 | 4 | 82 | 0 | 51 |
| 2020 | 0 | — | 0 | 61 |
| 2021 | 0 | — | 0 | 74 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 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 2.0 mm and less than 1.5 mm 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.
https://510kreport.com/device/K183615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183615
Report an extraction error
Are you the manufacturer?
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