510(k) · Cleared
ClearedMicrofuse Membrane Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Med Corp. · KRA Catheter, Continuous Flush
Cleared on Feb 27, 1998 as substantially equivalent to K932616 (Scimed Life Systems, Inc., 1993) and 1 other predicate after a 302-day review. Its family tree reaches back 1 generation to 1993. 18 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 302 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K932616 (1993). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932616 Scimed (R) Dispatch (TM) Coronary Infusion CatheterScimed Life Systems, Inc. · 1993
- This deviceK971619 Microfuse Membrane Infusion CatheterE-Med Corp. · 1998
- Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
- Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- Descendant · 3 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 4 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
- K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
- K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 3 generations on9descendants
- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932616 | Scimed (R) Dispatch (TM) Coronary Infusion Catheter | Scimed Life Systems, Inc. | 1993 | — |
| 0 (this device) | K971619 | Microfuse Membrane Infusion Catheter | E-Med Corp. | 1998 | — |
| +1 | K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | Kerberos Proximal Solutions, Inc. | 2004 | — |
| +2 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| +3 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| +3 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +4 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K933549 | FDA’s K933549 is Vidas CMV Igm Assay Our OCR of the scanned summary read K933549, FDA’s number for Vidas CMV Igm Assay (Biomerieux Vitek, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter”. Kept off the family tree. Summary page 1…Membrane Infusion Catheter CLASSIFICATION NAME Catheter, Infusion and NUMBER: 21 CFR, 870.1250 PREDICATE DEVICES: LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter, K933549 Scimed - Dispatch Catheter, K932616 Cardiovascular Dynamics Inc. (CDI) BULLETT™ Infusion Catheter, K931027 DEVICE DESCRIPTION:… | 1994 |
| * | K932616 | Scimed (R) Dispatch (TM) Coronary Infusion CatheterSummary page 1…CATION NAME Catheter, Infusion and NUMBER: 21 CFR, 870.1250 PREDICATE DEVICES: LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter, K933549 Scimed - Dispatch Catheter, K932616 Cardiovascular Dynamics Inc. (CDI) BULLETT™ Infusion Catheter, K931027 DEVICE DESCRIPTION: The Microfuse Membrane Infusion Cath… | 1993 |
| * | K931027 | Bullett Peripheral Infusion CatheterSummary page 1…EVICES: LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter, K933549 Scimed - Dispatch Catheter, K932616 Cardiovascular Dynamics Inc. (CDI) BULLETT™ Infusion Catheter, K931027 DEVICE DESCRIPTION: The Microfuse Membrane Infusion Catheter is a non-dilatation, over-the- wire infusion device designed for lo… | 1994 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 | 2004 | 17 |
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?
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?
E-Med’s Microfuse Membrane Infusion Catheter is a nondilatation over-the-wire device intended for the localized infusion of therapeutic solution(s) in the coronary vasculature through a microporous membrane. The catheter is intended to be coaxially tracked over a guidewire to access a subselective infusion region in the coronary vasculature. The technique, rate of administration, duration of infusion, and appropriate sizing of the membrane to the arterial diameter is determined by the operating physician. The infusion solution should be used in accordance with the manufacturer’s instructions for use.
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/K971619 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971619: Microfuse Membrane Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971619
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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