De Novo · Granted
GrantedVasQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laminate Medical Technologies, Ltd. · QVQ Extravascular Support For An Arteriovenous Fistula For Vascular Access
Granted on Sep 26, 2023 as a new device type through De Novo after a 515-day review. 1 later device descends from it.
- Decided
- Sep 26, 2023
- Review
- 515 days
- Class
- Class II
- Product code
- QVQ
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN220026 VasQLaminate Medical Technologies, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240119 VasQLaminate Medical Technologies, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240119VasQLaminate Medical Technologies, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220026 | VasQ | Laminate Medical Technologies, Ltd. | 2023 | — |
| +1 | K240119 | VasQ | Laminate Medical Technologies, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 QVQ? 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 QVQ device
- #1 K240119 VasQscore 6.9 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K240119 | VasQ | 2024 | 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?
- Of its descendants, K240119 (Laminate Medical Technologies, Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QVQ devicesQVQ Extravascular Support For An Arteriovenous Fistula For Vascular Access: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QVQ
Too few QVQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QVQ
No recall names QVQ since 2007.
Adverse event reports per year · QVQ
No MAUDE report names QVQ since 2007.
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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220026 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220026: VasQ.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220026
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