510(k) · Cleared
ClearedPrimi Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermopeutix, Inc. · DQY Catheter, Percutaneous
Cleared on Sep 26, 2013 as substantially equivalent to K130850 (Thermopeutix, Inc., 2013) after a 28-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Sep 26, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130850 (2013). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK130850 Primi and Secondi Support CathetersThermopeutix, Inc. · 2013
- This deviceK132701 Primi Support CatheterThermopeutix, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK183305 Crossing Support CatheterTractus Vascular, LLC · 2019
- Descendant · cites it directly · 0 of its ownK180889 Tractus Crossing Support CatheterTractus Vascular, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130850 | Primi and Secondi Support Catheters | Thermopeutix, Inc. | 2013 | — |
| 0 (this device) | K132701 | Primi Support Catheter | Thermopeutix, Inc. | 2013 | — |
| +1 | K183305 | Crossing Support Catheter | Tractus Vascular, LLC | 2019 | — |
| +1 | K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K130850 | Primi and Secondi Support CathetersSummary page 1…nced hydrophilic coating is substantially equivalent in indications, design, construction and features to the ThermopeutiX Primi tm Support Catheter cleared under 510(k) K130850 with the exception of the hydrophilic coating.… | 2013 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K183305 (Tractus Vascular, LLC, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Primim Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132701: Primi Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132701
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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