510(k) · Cleared
ClearedDuflo Catheter (Heparin Coated)
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 Aug 25, 2010 as substantially equivalent to K080700 (Thermopeutix, Inc., 2008) after a 252-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Aug 25, 2010
- Review
- 252 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974236 (1999). 16 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 3 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 2 generations backK023914 Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
- 1 generation backK080700 Duoflo CatheterThermopeutix, Inc. · 2008
- This deviceK093847 Duflo Catheter (Heparin Coated)Thermopeutix, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −3 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −2 | K023914 | Coaxia Flocontrol Catheter | Coaxia, Inc. | 2003 | — |
| −1 | K080700 | Duoflo Catheter | Thermopeutix, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K080700 | Duoflo CatheterSummary page 1…Flo' TM Catheter (Heparin Coated) is substantially equivalent in indications, design, construction and features to the ThermopeutiX DuoFloTM catheter cleared under 510Ok K080700 with the exception that bound heparin has been included in the catheter's hydrophilic coating..… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K080700.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 DuoFlom 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 DuoFIoTM Catheter is contraindlicated for use in the coronary and intracranial arteries.
The DuoFlom 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/K093847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093847: Duflo Catheter (Heparin Coated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093847
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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