510(k) · Cleared
ClearedMercator Microsyringe II Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercator Medsystems, Inc. · KRA Catheter, Continuous Flush
Cleared on Dec 7, 2006 as substantially equivalent to K040139 (Endobionics, Inc., 2004) and 3 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1991. 8 later devices descend from it.
- Decided
- Dec 7, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K913517 (1991). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 1 generation backK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- This deviceK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK153501 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK213442 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022
- Descendant · 3 generations on · 0 of its ownK254051 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140637Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014 · cites it directly6descendants
- K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · cites it directly5descendants
- K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · cites it directly4descendants
- K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022 · 2 generations on1descendant
- K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −1 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| 0 (this device) | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| +1 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| +1 | K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| +1 | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| +2 | K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022 | — |
| +3 | K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K040139 | Endobionics Microsyringe (Usyringe) Infusion CatheterSummary page 1…assification KRA/Class II Panel Cardiovascular Predicate Devices Mercator MicroSyringe Infusion Catheter K040139 Manufactured by Mercator MedSystems, Inc Dispatch Coronary Infusion Catheter K932616 Manufactured… | 2004 |
| * | K932616 | Scimed (R) Dispatch (TM) Coronary Infusion CatheterSummary page 1…Mercator MicroSyringe Infusion Catheter K040139 Manufactured by Mercator MedSystems, Inc Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED® Life Systems, Inc. Selective Infusion II Catheter K914751 Manufacture… | 1993 |
| * | K914751 | Selective Infusion II CatheterSummary page 1…Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED® Life Systems, Inc. Selective Infusion II Catheter K914751 Manufactured by ACS®/Guidant, Inc Isolate Infusion Catheter System K913517 Manufactured by Lake… | 1993 |
| * | K913517 | Isolate Infusion Cathetr SystemSummary page 1…Inc. Selective Infusion II Catheter K914751 Manufactured by ACS®/Guidant, Inc Isolate Infusion Catheter System K913517 Manufactured by Lake Region, Inc. DeviceDescription The Mercator MicroSyringe II is a wire-guided endovascular cathe… | 1991 |
What descends from it? (8)
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)
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 15 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140637 (Ablative Solutions, Inc., 2014) has gone furthest, with 6 descendants of its own.
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?
In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062752: Mercator Microsyringe II Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062752
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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