510(k) · Cleared
ClearedDuoflo Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermopeutix, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Sep 26, 2008 as substantially equivalent to K003288 (Origen Biomedical, Inc., 2001) and 2 other predicates after a 199-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K974236 (1999). 15 ancestors in all, the oldest K811742 (1981). 3 later devices descend from it, 2 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 deviceK080700 Duoflo CatheterThermopeutix, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK112219 Tapas CatheterThermopeutix, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK141175 Renovocath RC120Renovorx, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK093847 Duflo Catheter (Heparin Coated)Thermopeutix, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView 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) | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | — |
| +1 | K112219 | Tapas Catheter | Thermopeutix, Inc. | 2011 | — |
| +2 | K141175 | Renovocath RC120 | Renovorx, Inc. | 2014 | 1 |
| +1 | K093847 | Duflo Catheter (Heparin Coated) | Thermopeutix, Inc. | 2010 | — |
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 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K003288 | Origen Dual Lumen CatheterSummary page 1…gn and features to temporary occluding catheters, perfusion catheters and diagnostic intravascular catheters; these devices are: 1) OriGen Dual Lumen Catheter (K003288) - DQO 2) Coaxia FloControl TM Catheter (K023914) - MJN 3) Estech Remote Access Perfusion Catheter (K990573) - DXC… | 2001 |
| * | K023914 | Coaxia Flocontrol CatheterSummary page 1…erfusion catheters and diagnostic intravascular catheters; these devices are: 1) OriGen Dual Lumen Catheter (K003288) - DQO 2) Coaxia FloControl TM Catheter (K023914) - MJN 3) Estech Remote Access Perfusion Catheter (K990573) - DXC Page 1 of… | 2003 |
| * | K990573 | Estech Arterial Remote Access Perfusion CannulaSummary page 1…e devices are: 1) OriGen Dual Lumen Catheter (K003288) - DQO 2) Coaxia FloControl TM Catheter (K023914) - MJN 3) Estech Remote Access Perfusion Catheter (K990573) - DXC Page 1 of 2… | 1999 |
What descends from it? (3)
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 9 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K112219 (Thermopeutix, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K003288.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 DuoFIoTM Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.
The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080700 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080700: Duoflo Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080700
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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