510(k) · Cleared
ClearedCatalyst II and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiva Medical, Inc. · DXC Clamp, Vascular
Cleared on Mar 14, 2013 as substantially equivalent to K082930 (Cardiva Medical, Inc., 2009) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Mar 14, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915280 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK915280 FemostopRadi Medical Systems AB · 1992
- 4 generations backK051817 Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc. · 2006
- 3 generations backK070485 Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc. · 2007
- 2 generations backK072297 Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc. · 2007
- 1 generation backK082930 Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc. · 2009
- This deviceK130124 Catalyst II and IiiCardiva Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915280 | Femostop | Radi Medical Systems AB | 1992 | — |
| −4 | K051817 | Boomerang Closurewire Vascular Closure System | Cardiva Medical, Inc. | 2006 | — |
| −3 | K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L | Cardiva Medical, Inc. | 2007 | — |
| −2 | K072297 | Boomerang Catalyst/Boomerang Catalyst II System | Cardiva Medical, Inc. | 2007 | — |
| −1 | K082930 | Cardiva Catalyst Iii System with Protamine Sulfate | Cardiva Medical, Inc. | 2009 | — |
| 0 (this device) | K130124 | Catalyst II and Iii | Cardiva Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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 |
|---|---|---|---|
| * | K082930 | Cardiva Catalyst Iii System with Protamine SulfateSummary page 1…Vascular Clamp Product Code/ Regulation: DXC / (21 CFR §870.4450) Classification: Class 11 Predicate Device: Catalyst T M11 and Ill K082930, K072297, and K070485 Device Description: The Cardiva Catalyst systems are intended to promote hemostasis at arteriotomy sites a… | 2009 |
| * | K072297 | Boomerang Catalyst/Boomerang Catalyst II SystemSummary page 1…Vascular Clamp Product Code/ Regulation: DXC / (21 CFR §870.4450) Classification: Class 11 Predicate Device: Catalyst T M11 and Ill K082930, K072297, and K070485 Device Description: The Cardiva Catalyst systems are intended to promote hemostasis at arteriotomy sites as adjunct… | 2007 |
| * | K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LSummary page 1…amp Product Code/ Regulation: DXC / (21 CFR §870.4450) Classification: Class 11 Predicate Device: Catalyst T M11 and Ill K082930, K072297, and K070485 Device Description: The Cardiva Catalyst systems are intended to promote hemostasis at arteriotomy sites as adjuncts to manual c… | 2007 |
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 21 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
The Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Catalyst III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130124: Catalyst II and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130124
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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