510(k) · Cleared
Recalled · Class II · 2017Grebset Micro-Introducer Kit, Models 7950, 7951
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 28, 2009 as substantially equivalent to K073585 (Vascular Solutions, Inc., 2008) after a 212-day review. Its family tree reaches back 5 generations to 1981. 2 of the 12 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jan 28, 2009
- Review
- 212 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810412 (1981). 11 ancestors in all. No later device cites it as a predicate yet. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 4 generations backK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- 3 generations backK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- 2 generations backK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- 1 generation backK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
- This deviceK081846 Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc. · 2009
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| −4 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| −3 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
| −2 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| −1 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| 0 (this device) | K081846 | Grebset Micro-Introducer Kit, Models 7950, 7951 | Vascular Solutions, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 1 |
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.
2 devices in this family have a Class I recall. 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Summary page 1…DQO Regulation: 21 CFR 870.1200 Predicate Devices Vascular Solutions; InnerChange 'Micro-Introducer Catheter (K073585) Boston Scientific; AccuStick II (K unknown) Cook Medical; Neff Percutaneous Access Set (K unknown) Device Descrip… | 2008 |
| * | — | AccuStick II Named without a submission number | |
| * | — | Neff Percutaneous Access Set Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2017 | Class II | Z-1250-2017 | Error in labeling | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081846: Grebset Micro-Introducer Kit, Models 7950, 7951.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081846
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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