510(k) Report

510(k) · Cleared

Cleared

Reprieve Endovascular Temperature Therapy System

K071358510(k) TraditionalCleared Jun 1, 200717-day reviewClass II21 CFR 870.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Radiant Medical · NCX System, Hypothermia, Intravenous, Cooling

Cleared on Jun 1, 2007 as substantially equivalent to K012512 (Radiant Medical, 2002) and 3 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1981.

Decided
Jun 1, 2007
Review
17 days
Class
Class II
Product code
NCX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K811742 (1981). 16 ancestors in all, the oldest K811743 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2001: 1 other ancestor2000: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor1989: 2 other ancestors1981: 1 other ancestorReference device: K042388 · Radiant Medical Endocatheter Temperature Probe · Radiant Medical · 2004K811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalledK012512 · Setpoint Endovascular Temperature Management System · Radiant Medical · 2002K022366 · Celsius Control System · Innercool Therapies · 2003K030421 · Alsius Coolgard 3000 & Alsius Catheter System · Alsius Corp. · 2003 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 11 other ancestors K030421 · Alsius Coolgard 3000 & Alsius Catheter System · Alsius Corp. · 2003 · recalledK022366 · Celsius Control System · Innercool Therapies · 2003K012512 · Setpoint Endovascular Temperature Management System · Radiant Medical · 2002K811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalled0
  1. Root · 4 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
  2. 3 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
  3. 2 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
  4. 1 generation backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
  5. This deviceK071358 Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K811742Hemotherm Model 400Cincinnati Sub-Zero19812
−3K012512Setpoint Endovascular Temperature Management SystemRadiant Medical2002—
−2K022366Celsius Control SystemInnercool Therapies2003—
−1K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.20034
0 (this device)K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198920
199010
199120
199310
200030
200110
200710
FIG. 1 — Lineage of K071358, 1981–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 10.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012512Setpoint Endovascular Temperature Management System
Summary page 1
…II Product Code: NCX Predicate Devices a) The Radiant Medical Reprieve® Endovascular Temperature Therapy System cleared under K012512 (decision dated June 11, 2002) and special K063405 (decision dated January 8, 2007). b) The Innercool Celsius Contro…
Radiant Medical2002—
*K063405Reprieve Endovascular Temperature Therapy System
Summary page 1
…Predicate Devices a) The Radiant Medical Reprieve® Endovascular Temperature Therapy System cleared under K012512 (decision dated June 11, 2002) and special K063405 (decision dated January 8, 2007). b) The Innercool Celsius Control SystemTM cleared under K022366 (decision…
Radiant Medical2007—
*K022366Celsius Control System
Summary page 1
…d under K012512 (decision dated June 11, 2002) and special K063405 (decision dated January 8, 2007). b) The Innercool Celsius Control SystemTM cleared under K022366 (decision dated January 27, 2003). c) The Alsius CoolGard® and CoolLine® Catheter Thermal Regulation System…
Innercool Therapies2003—
*K030421Alsius Coolgard 3000 & Alsius Catheter System
Summary page 1
…mTM cleared under K022366 (decision dated January 27, 2003). c) The Alsius CoolGard® and CoolLine® Catheter Thermal Regulation System cleared under K030421 (decision dated October 23, 2003). 2…
Alsius Corp.20034
†K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical2004—

Also cleared against K012512: 6 other devices →

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 26 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
  • 7 of the 16 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K012512.

How does its category compare?

All NCX devices

NCX 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

2007: 62008: 32010: 12014: 12015: 12016: 32021: 12022: 12023: 1
2007high 6 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCX

204in 2016

2007: 28 days median2008: 129 days median2016: 204 days median
2007high 204 (2016) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NCX

28in 2021

2007: 22014: 12021: 28
2007high 28 (2021) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NCX

273in 2025

2007: 42008: 82009: 42010: 92011: 72012: 142013: 312014: 412015: 322016: 3112017: 4502018: 5092019: 4362020: 4152021: 4612022: 5112023: 3732024: 3432025: 273
2007high 511 (2022) · low 4 (2007)2025

MAUDE reports naming product code NCX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200762824
2008312908
20090—04
20101—09
20110—07
20120—014
20130—031
20141—141
20151—032
201632040311
20170—0450
20180—0509
20190—0436
20200—0415
20211—28461
20221—0511
20231—0373
20240—0343
20250—0273
20260—0—

What is it indicated for?

The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Indications for use as stated in the FDA summary.

Also cleared against K012512

6 other devices cite the same predicate.

  • K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
  • K033623Celsius Control SystemInnercool Therapies, Inc. · 2004
  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 20034 recalls
  • K024327Setpoint Endovascular Temperature ProbeRadiant Medical · 2003
  • K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 2003
  • K022366Celsius Control SystemInnercool Therapies · 2003

More from Radiant Medical

6 FDA decisions under this applicant name. See the company

  • K071008Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
  • K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical · 2007
  • K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical · 2004
  • K024327Setpoint Endovascular Temperature ProbeRadiant Medical · 2003
  • K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002

Recent decisions in NCX

The NCX category page

  • K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2023
  • K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2022
  • K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2021
  • K152946TempedySeiratherm GmbH · 2016
  • K153162HypocoreNovocor Medical Systems, Inc. · 2016

https://510kreport.com/device/K071358 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071358: Reprieve Endovascular Temperature Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071358

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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