510(k) · Cleared
ClearedSetpoint Endovascular Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiant Medical · DQY Catheter, Percutaneous
Cleared on Mar 25, 2003 as substantially equivalent to K012512 (Radiant Medical, 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Mar 25, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K811742 (1981). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 1 generation backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- This deviceK024327 Setpoint Endovascular Temperature ProbeRadiant Medical · 2003
- Descendant · cites it directly · 0 of its ownK042388 Radiant Medical Endocatheter Temperature ProbeRadiant Medical · 2004
Most influential descendants
Showing 1 of 1 · See all- K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −1 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| 0 (this device) | K024327 | Setpoint Endovascular Temperature Probe | Radiant Medical | 2003 | — |
| +1 | K042388 | Radiant Medical Endocatheter Temperature Probe | Radiant Medical | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K012512 | Setpoint Endovascular Temperature Management SystemSummary page 2…10993. The SetPoint Controller has been tested for electrical safety in accordance to EN 60601, as previously reported in K012512. Conclusion Based upon the successful performance tests and… | 2002 |
| * | K904404 | Multi-Lumen Central Venous Catheter SetSummary page 1…(KO 125 12) b) The Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). Indication for Use ~… | 1991 |
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 |
|---|---|---|---|
| K042388 | Radiant Medical Endocatheter Temperature Probe | 2004 | 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 22 years and passes through 2 companies; a new generation was cleared every 20.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K042388 (Radiant Medical, 2004) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K012512.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SetPoint Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024327: Setpoint Endovascular Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024327
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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