510(k) · Cleared
ClearedMoerae Vein Preparation Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moerae Matrix, Inc. · GBX Catheter, Irrigation
Cleared on Mar 3, 2014 as substantially equivalent to K000704 (Dmc Medical, Ltd., 2000) and 1 other predicate after a 270-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 3, 2014
- Review
- 270 days
- Class
- Class I
- Product code
- GBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000704 (2000). 4 ancestors in all, the oldest K853586 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK000704 DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000
- 2 generations backK043515 GraftsaverVescare, Inc. · 2005
- 1 generation backK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · Recalled
- This deviceK131659 Moerae Vein Preparation KitMoerae Matrix, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000704 | DMC Saphenous Vein Distention System (SVDS) | Dmc Medical, Ltd. | 2000 | — |
| −2 | K043515 | Graftsaver | Vescare, Inc. | 2005 | — |
| −1 | K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular, LLC | 2008 | 1 |
| 0 (this device) | K131659 | Moerae Vein Preparation Kit | Moerae Matrix, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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? (2)
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 |
|---|---|---|---|
| * | K000704 | DMC Saphenous Vein Distention System (SVDS) Our reading of the summary gave K000104, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OMG Saphenous Vein Distension System”. | 2000 |
| * | K082725 | Graftguard Pressure Controlling SyringeSummary page 1…ubstantially equivalent in intended use and/or method of operation to the 0MG Saphenous Vein Distension System (KO00104) and the Vasoshield Pressure Controlling Syringe (K082725). Test Results: Performance Results of in-vitro testing, including valve cracking pressure and system leakage, demonstrate that t… | 2008 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K000704.
How does its category compare?
All GBX devicesGBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 VasoPrep Vein Preparation Kit is a sterilized convenience kit 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/K131659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131659: Moerae Vein Preparation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131659
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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