510(k) · Cleared
ClearedCoaxia Flocontrol Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coaxia, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Feb 21, 2003 as substantially equivalent to K990487 (Micro Therapeutics, Inc., 1999) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1999. 6 later devices descend from it.
- Decided
- Feb 21, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K974236 (1999). 12 ancestors in all, the oldest K811742 (1981). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 1 generation backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- This deviceK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK080700 Duoflo CatheterThermopeutix, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK112219 Tapas CatheterThermopeutix, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK090970 Flocontrol , Model 1028Coaxia, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK192786 Gatekeeper Balloon CatheterArch Catheter, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK141175 Renovocath RC120Renovorx, Inc. · 2014 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080700Duoflo CatheterThermopeutix, Inc. · 2008 · cites it directly3descendants
- K112219Tapas CatheterThermopeutix, Inc. · 2011 · 2 generations on1descendant
- K090970Flocontrol , Model 1028Coaxia, Inc. · 2009 · cites it directly1descendant
- K192786Gatekeeper Balloon CatheterArch Catheter, LLC · 2020 · 2 generations on0descendants
- K141175Renovocath RC120Renovorx, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −1 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| 0 (this device) | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| +1 | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | — |
| +2 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| +1 | K090970 | Flocontrol , Model 1028 | Coaxia, Inc. | 2009 | — |
| +2 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | — |
| +3 | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K990487 | Equinox Occlusion Balloon SystemSummary page 1…Name: CoAxia FloControlTMCatheter Common Name: Peripheral Vascular Occlusion Balloon Predicate Device(s): EquinoxTMOcclusion Balloon System (K990487) HeartportB Endoaortic ClampTMCatheter (K974 175) MedCompB DUO-COAT Cathete… | 1999 |
| * | K974175 | Heartport Endoaortic Clamp CatheterSummary page 1…heral Vascular Occlusion Balloon Predicate Device(s): EquinoxTMOcclusion Balloon System (K990487) HeartportB Endoaortic ClampTMCatheter (K974 175) MedCompB DUO-COAT Catheter Double Lumen (K991320) SetPointB Endovascular T… | 1997 |
| * | K991320 | Medcomp Duo-Flow II Catheter with Lubricious HeparinSummary page 1…Balloon System (K990487) HeartportB Endoaortic ClampTMCatheter (K974 175) MedCompB DUO-COAT Catheter Double Lumen (K991320) SetPointB Endovascular Temperature Management System (KO 12512) Dev… | 1999 |
| * | K012512 | Setpoint Endovascular Temperature Management System | 2002 |
What descends from it? (6)
2 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 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K080700 (Thermopeutix, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K990487.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023914: Coaxia Flocontrol Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023914
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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