510(k) · Cleared
ClearedDMC Saphenous Vein Distention System (SVDS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmc Medical, Ltd. · GBX Catheter, Irrigation
Cleared on May 19, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 19, 2000
- Review
- 78 days
- Class
- Class I
- Product code
- GBX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK000704 DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000
- Descendant · cites it directly · 6 of its ownK043515 GraftsaverVescare, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK140603 Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K043515GraftsaverVescare, Inc. · 2005 · cites it directly6descendants
- K082725Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · cites it directly5descendants
- K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · 2 generations on2descendants
- K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC · 2019 · 3 generations on0descendants
- K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000704 | DMC Saphenous Vein Distention System (SVDS) | Dmc Medical, Ltd. | 2000 | — |
| +1 | K043515 | Graftsaver | Vescare, Inc. | 2005 | — |
| +1 | K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular, LLC | 2008 | 1 |
| +2 | K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | Maquet Cardiovascular, LLC | 2009 | 1 |
| +3 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar… | Maquet Cardiovascular, LLC | 2019 | — |
| +3 | K140603 | Onepass Endoscopic Vessel Harvesting Sysyetm | Saphena Medical, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K043515 (Vescare, Inc., 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GBX devicesGBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBX
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · GBX
Too few GBX 510(k)s in any year since 2007 to give a median.
Recalls per year · GBX
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GBX
1,179in 2025
MAUDE reports naming product code GBX, 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 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 1 | 35 |
| 2011 | 0 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 1 | — | 0 | 51 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 0 | — | 0 | 86 |
| 2017 | 0 | — | 1 | 176 |
| 2018 | 0 | — | 0 | 277 |
| 2019 | 0 | — | 0 | 196 |
| 2020 | 0 | — | 0 | 198 |
| 2021 | 0 | — | 1 | 383 |
| 2022 | 0 | — | 29 | 477 |
| 2023 | 0 | — | 0 | 628 |
| 2024 | 0 | — | 0 | 945 |
| 2025 | 0 | — | 6 | 1,179 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000704: DMC Saphenous Vein Distention System (SVDS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000704
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026