510(k) · Cleared
Recalled · Class II · 2022Graftguard Pressure Controlling Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · GBX Catheter, Irrigation
Cleared on Dec 17, 2008 as substantially equivalent to K043515 (Vescare, Inc., 2005) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 2008
- Review
- 91 days
- Class
- Class I
- Product code
- GBX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000704 (2000). 3 ancestors in all, the oldest K853586 (1985). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000704 DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000
- 1 generation backK043515 GraftsaverVescare, Inc. · 2005
- This deviceK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008
- Descendant · cites it directly · 2 of its ownK091733 Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK140603 Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK131659 Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK110993 Femchec Pressure Managemet DeviceFemasys, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC · 2009 · cites it directly2descendants
- K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC · 2019 · 2 generations on0descendants
- K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 2014 · 2 generations on0descendants
- K131659Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014 · cites it directly0descendants
- K110993Femchec Pressure Managemet DeviceFemasys, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000704 | DMC Saphenous Vein Distention System (SVDS) | Dmc Medical, Ltd. | 2000 | — |
| −1 | K043515 | Graftsaver | Vescare, Inc. | 2005 | — |
| 0 (this device) | K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular, LLC | 2008 | — |
| +1 | K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500 | Maquet Cardiovascular, LLC | 2009 | 1 |
| +2 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar… | Maquet Cardiovascular, LLC | 2019 | — |
| +2 | K140603 | Onepass Endoscopic Vessel Harvesting Sysyetm | Saphena Medical, Inc. | 2014 | 1 |
| +1 | K131659 | Moerae Vein Preparation Kit | Moerae Matrix, Inc. | 2014 | — |
| +1 | K110993 | Femchec Pressure Managemet Device | Femasys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K043515 | GraftsaverSummary page 1…ded use of the substantial VASOSHIELD Pressure Controlling Syringe are substantially equivalent to the equivalence predicate devices: InPress Syringe, (K043515, cleared on March 31, 2005), the DMC Saphenous Vein System (K000704, cleared on May 19, 2000), and the… | 2005 |
| * | K000704 | DMC Saphenous Vein Distention System (SVDS)Summary page 1…ally equivalent to the equivalence predicate devices: InPress Syringe, (K043515, cleared on March 31, 2005), the DMC Saphenous Vein System (K000704, cleared on May 19, 2000), and the DLP Pressure Sensing Syringe (K853586, cleared on November 14, 1985). Dev… | 2000 |
| * | K853586 | Pressure Sensing Syringe 65000Summary page 1…red on March 31, 2005), the DMC Saphenous Vein System (K000704, cleared on May 19, 2000), and the DLP Pressure Sensing Syringe (K853586, cleared on November 14, 1985). Device The VASOSHIELD Pressure Controlling Syringe is identical to the InPress desc… | 1985 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2022 | Class II | Z-0996-2023 | Under Investigation by firm | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091733 (Maquet Cardiovascular, LLC, 2009) has gone furthest, with 2 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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082725: Graftguard Pressure Controlling Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082725
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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