510(k) · Cleared
ClearedBullfrog Micro-Infusion Device
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 Aug 18, 2016 as substantially equivalent to K153501 (Mercator Medsystems, Inc., 2016) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Aug 18, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913517 (1991). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 3 generations backK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- 2 generations backK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- 1 generation backK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- This deviceK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK213442 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022
- Descendant · 2 generations on · 0 of its ownK254051 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
- Descendant · cites it directly · 0 of its ownK222185 Stratus Infusion CatheterIntervene, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK210339 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022 · cites it directly1descendant
- K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026 · 2 generations on0descendants
- K222185Stratus Infusion CatheterIntervene, Inc. · 2023 · cites it directly0descendants
- K210339Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −3 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| −2 | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| −1 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| 0 (this device) | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| +1 | K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022 | — |
| +2 | K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026 | — |
| +1 | K222185 | Stratus Infusion Catheter | Intervene, Inc. | 2023 | — |
| +1 | K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 14.5 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153501 | Bullfrog Micro-Infusion DeviceSummary page 4…e KRA Panel: Cardiovascular Predicate Device 510(k) Trade or Proprietary or Model Name Manufacturer Number K153501 Bullfrog® Micro-Infusion Device Mercator MedSystems Reference Devices 510(k) T… | 2016 |
| * | K140637 | Peregrine System Infusion CatheterSummary page 4…Device Mercator MedSystems Reference Devices 510(k) Trade or Proprietary or Model Name Manufacturer Number K140637 Peregrine System Infusion Catheter Ablative Solutions MicroSyringe II/Bullfrog Micro-Infu… | 2014 |
| * | K062752 | Mercator Microsyringe II Infusion CatheterSummary page 4…Manufacturer Number K140637 Peregrine System Infusion Catheter Ablative Solutions MicroSyringe II/Bullfrog Micro-Infusion K062752 Mercator MedSystems Device Device Description The Mer… | 2006 |
What descends from it? (4)
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 25 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K213442 (SmartWise Sweden AB, 2022) has gone furthest, with 1 descendant 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. 2016, this device’s year, is highlighted.
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 Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161402 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161402: Bullfrog Micro-Infusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161402
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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