De Novo · Granted
GrantedEllipsys Vascular Access System
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
Granted on Jun 22, 2018 as a new device type through De Novo after a 528-day review. 3 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 528 days
- Class
- Class II
- Product code
- PQK
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN170004 Ellipsys Vascular Access SystemAvenu Medical, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK181725 Ellipsys Vascular Access System (Ellipsys System), (Power Controller…Avenu Medical, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK183615 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK191114 Ellipsys Vascular Access System (Ellipsys System), Power Controller…Avenu Medical · 2019
Most influential descendants
Showing 3 of 3 · See all- K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001…Avenu Medical, Inc. · 2018 · cites it directly2descendants
- K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…Avenu Medical, Inc. · 2019 · 2 generations on1descendant
- K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…Avenu Medical · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys… | Avenu Medical, Inc. | 2019 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001… | 2018 | 2 |
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?
- Of its descendants, K181725 (Avenu Medical, Inc., 2018) has gone furthest, with 2 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. 2018, 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 2.0mm 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.
https://510kreport.com/device/DEN170004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170004: Ellipsys Vascular Access System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170004
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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