510(k) · Cleared
ClearedVasQ
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
Cleared on Feb 16, 2024 as substantially equivalent to DEN220026 (Laminate Medical Technologies, Ltd., 2023) after a 31-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Feb 16, 2024
- Review
- 31 days
- Class
- Class II
- Product code
- QVQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220026 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220026 VasQLaminate Medical Technologies, Ltd. · 2023
- This deviceK240119 VasQLaminate Medical Technologies, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220026 | VasQ | Laminate Medical Technologies, Ltd. | 2023 | — |
| 0 (this device) | K240119 | VasQ | Laminate Medical Technologies, Ltd. | 2024 | — |
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 QVQ? 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 |
|---|---|---|---|
| * | DEN220026 | VasQSummary page 5…venous fistula for vascular access Classification 21 CFR 870.4600, Class II, Product code QVQ Predicate Device Laminate Medical Technologies Ltd, VasQ (DEN220026) Intended Use VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created… | 2023 |
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?
- Its one ancestor has no recall.
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. 2024, 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/K240119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240119: VasQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240119
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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