510(k) · Cleared
ClearedTherox Infusion Catheter, Model Inca-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therox, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 8, 2006 as substantially equivalent to K853997 (Target Therapeutics, 1985) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Mar 8, 2006
- Review
- 163 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K853997 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK853997 Infusion CatheterTarget Therapeutics · 1985
- This deviceK052637 Therox Infusion Catheter, Model Inca-1Therox, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853997 | Infusion Catheter | Target Therapeutics | 1985 | — |
| 0 (this device) | K052637 | Therox Infusion Catheter, Model Inca-1 | Therox, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K853997 | Infusion CatheterSummary page 1…ufactured by TherOx, Inc., is substantially equivalent to the Boston Scientific/Target Therapeutics Tracker® - 38 Infusion Catheter cleared for market under 51 0(k) nos. K853997 and K•862117. 1 Both catheters are intended to enable delivery of diagnostic and therapeutic solutions into the peripheral and co… | 1985 |
| * | K862117 | Tracker Infusion CatheterSummary page 1…herOx, Inc., is substantially equivalent to the Boston Scientific/Target Therapeutics Tracker® - 38 Infusion Catheter cleared for market under 51 0(k) nos. K853997 and K•862117. 1 Both catheters are intended to enable delivery of diagnostic and therapeutic solutions into the peripheral and coronary vascul… | 1986 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K853997.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052637: Therox Infusion Catheter, Model Inca-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052637
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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