510(k) · Cleared
ClearedVasoring* VRC Vascular Ring Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunwei Tech Co., Ltd. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Oct 5, 2006 as substantially equivalent to K881283 (Meadox Medicals, Div. Boston Scientific Corp., 1988) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Oct 5, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970793 (1997). 4 ancestors in all, the oldest K881283 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970793 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K003446 | Symmetry Aortic Clip System | St. Jude Medical Cardiovascular Group, Inc. | 2001 | — |
| 0 (this device) | K061626 | Vasoring* VRC Vascular Ring Connector | Sunwei Tech Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 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 DSY? 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 DSY device
- #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K881283 | Meadox Intra-Aortic GraftSummary page 1…t, of 6mm and Greater Diameter 3. Predicate Device Trade Name 5 10(k Number Decision Date Meadox Intra-Aortic Graft K881283 05/26/1988 Titanium GREENFIELD Vena Cava Filter K874096 11/04/1988 St. Jude Symmetry Aorti… | 1988 |
| * | K874096 | Titanium Greenfield Vena Cava Filter CarrierSummary page 1…5 10(k Number Decision Date Meadox Intra-Aortic Graft K881283 05/26/1988 Titanium GREENFIELD Vena Cava Filter K874096 11/04/1988 St. Jude Symmetry Aortic Clip K003446 05/2 1/2001 4. Device Descripti… | 1988 |
| * | K003446 | Symmetry Aortic Clip SystemSummary page 1…K881283 05/26/1988 Titanium GREENFIELD Vena Cava Filter K874096 11/04/1988 St. Jude Symmetry Aortic Clip K003446 05/2 1/2001 4. Device Description The vascular ring connector is made of biocompatible titanium alloy. Placed in… | 2001 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, 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 | 1 | — | 0 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The VASORING VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061626 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061626: Vasoring* VRC Vascular Ring Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061626
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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