510(k) · Cleared
ClearedReprieve Endovascular Temperature Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiant Medical · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Jan 8, 2007 as substantially equivalent to K012512 (Radiant Medical, 2002) after a 60-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Jan 8, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 1
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 deviceK063405 Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
- Descendant · cites it directly · 0 of its ownK071358 Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
Most influential descendants
Showing 1 of 1 · See all- K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007 · 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) | K063405 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | 2007 | — |
| +1 | K071358 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | 2007 | — |
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 |
|---|---|---|
| 2007 | 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 NCX? 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 NCX device
- #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 10.9 · 9 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 |
|---|---|---|---|
| * | K012512 | Setpoint Endovascular Temperature Management SystemSummary page 1…900 Class: II Product Code: NCX Predicate Device a) Radiant Medical SetPoint® Endovascular Temperature Management System (K012512). Indication for Use The Reprieve ® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patien… | 2002 |
| † | K042388 | Radiant Medical Endocatheter Temperature Probe | 2004 |
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 |
|---|---|---|---|
| K071358 | Reprieve Endovascular Temperature Therapy System | 2007 | 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 26 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, K071358 (Radiant Medical, 2007) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K012512.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NCX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NCX
204in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NCX
28in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NCX
273in 2025
MAUDE reports naming product code NCX, 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 | 6 | 28 | 2 | 4 |
| 2008 | 3 | 129 | 0 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 1 | — | 1 | 41 |
| 2015 | 1 | — | 0 | 32 |
| 2016 | 3 | 204 | 0 | 311 |
| 2017 | 0 | — | 0 | 450 |
| 2018 | 0 | — | 0 | 509 |
| 2019 | 0 | — | 0 | 436 |
| 2020 | 0 | — | 0 | 415 |
| 2021 | 1 | — | 28 | 461 |
| 2022 | 1 | — | 0 | 511 |
| 2023 | 1 | — | 0 | 373 |
| 2024 | 0 | — | 0 | 343 |
| 2025 | 0 | — | 0 | 273 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063405: Reprieve Endovascular Temperature Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063405
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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