510(k) · Cleared
ClearedFlocontrol , Model 1028
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 Jun 12, 2009 as substantially equivalent to K023914 (Coaxia, Inc., 2003) after a 67-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Jun 12, 2009
- Review
- 67 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K974236 (1999). 13 ancestors in all, the oldest K811742 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 2 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 1 generation backK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- This deviceK090970 Flocontrol , Model 1028Coaxia, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK192786 Gatekeeper Balloon CatheterArch Catheter, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K192786Gatekeeper Balloon CatheterArch Catheter, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −2 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −1 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| 0 (this device) | K090970 | Flocontrol , Model 1028 | Coaxia, Inc. | 2009 | — |
| +1 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K023914 | Coaxia Flocontrol CatheterSummary page 1…Trade Name: CoAxia FloControlTM Catheter Common Name: Peripheral Vascular Occlusion Balloon Predicate Device(s): CoAxia FloControl Tm Catheter (K023914) Classification Name: Catheter, Intravascular Occluding, Temporary Device Classification: Class II Product Code:… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192786 | Gatekeeper Balloon Catheter | 2020 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K192786 (Arch Catheter, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023914.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 flow in the peripheral vasculature, which includes the descending aorta.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090970: Flocontrol , Model 1028.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090970
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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