510(k) · Cleared
ClearedScimed Dispatch Gold Coronary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on Jul 3, 1996 as substantially equivalent to K953133 (Scimed Life Systems, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 3, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K950615 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK950615 Kaplan-Simpson Infusasleeve CatheterLocalmed, Inc. · 1995
- This deviceK961294 Scimed Dispatch Gold Coronary CatheterScimed Life Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950615 | Kaplan-Simpson Infusasleeve Catheter | Localmed, Inc. | 1995 | — |
| 0 (this device) | K961294 | Scimed Dispatch Gold Coronary Catheter | Scimed Life Systems, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953133 | Scimed Dispatch Coronary Infusion CatheterSummary page 1…. Frank (612) 494-2899 Continuous Flush Catheter (21CFR870.1210) Infusion Catheter SCIMED Dispatch Gold Coronary Catheter SCIMED Dispatch Coronary Infusion Catheter (K953133) and SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter (BK940029) LocalMed® InfusaSleeve™ Coronary Infusion Cathet… | 1996 |
| Kept off the family tree | K940029 | SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter The summary prints BK940029, a CBER number, which our reading took as K940029, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 1…heter SCIMED Dispatch Gold Coronary Catheter SCIMED Dispatch Coronary Infusion Catheter (K953133) and SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter (BK940029) LocalMed® InfusaSleeve™ Coronary Infusion Catheter (K950615) The Dispatch Gold Coronary Infusion Catheter is a non-dilatation,… | |
| * | K950615 | Kaplan-Simpson Infusasleeve CatheterSummary page 1…Coronary Infusion Catheter (K953133) and SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter (BK940029) LocalMed® InfusaSleeve™ Coronary Infusion Catheter (K950615) The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solut… | 1995 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961294 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961294: Scimed Dispatch Gold Coronary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961294
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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