510(k) · Cleared

Cleared

Setpoint Endovascular Temperature Management System

K012512510(k) TraditionalCleared Jun 11, 2002309-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 11, 2002 as substantially equivalent to K003724 (Medtronic Vascular, 2000) and 6 other predicates after a 309-day review. Its family tree reaches back 1 generation to 1981. 27 later devices descend from it.

Decided: Jun 11, 2002
Review: 309 days
Class: Class II
Product code: NCX
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K811742 (1981). 7 ancestors in all. 27 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
This deviceK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
Descendant · cites it directly · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
Descendant · cites it directly · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
Descendant · 2 generations on · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
Descendant · 3 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
Descendant · 3 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2003high 4 (2003) · low 0 (2006)2026

Most influential descendants

Showing 5 of 27 · See all

K022366Celsius Control SystemInnercool Therapies · 2003 · cites it directly16descendants
K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · cites it directly15descendants
K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · 2 generations on8descendants
K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 3 generations on7descendants
K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811742	Hemotherm Model 400	Cincinnati Sub-Zero	1981	2
0 (this device)	K012512	Setpoint Endovascular Temperature Management System	Radiant Medical	2002	—
+1	K022366	Celsius Control System	Innercool Therapies	2003	—
+1	K030421	Alsius Coolgard 3000 & Alsius Catheter System	Alsius Corp.	2003	4
+2	K052443	Icy Catheter, Model IC-3893A	Alsius Corp.	2005	—
+3	K070161	Quattro Catheter Model IC4593	Alsius Corp.	2007	—
+3	K101987	Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro…	Zoll Circulation	2010	—

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
2003	4	0
2004	2	0
2005	2	0
2007	3	0
2008	3	0
2009	1	0
2010	2	0
2011	1	0
2014	2	0
2015	1	0
2016	2	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K012512, 1981–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K003724	Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41…	Medtronic Vascular	2000	—
*	K894980	Bio-Cal 370 Heater/Cooler Summary page 1 …) The Medtronic cardiopulmonary bypass circuit composed of the: MYOTherm XPnf Cardioplegia Delivery System (KO03 7241, 3io-Cal 370 Tmperature Control Module (K894980), and Femoral cannula with introducer (K924642). b) The Cincinnati Sub-zero Hemothem 400 (KS11742). c) The Augustine…	Bio Medicus, Inc.	1989	1
*	K924642	Medtronic Bio-Medicus Femoral Cannula/Introducer Summary page 1 …ed of the: MYOTherm XPnf Cardioplegia Delivery System (KO03 7241, 3io-Cal 370 Tmperature Control Module (K894980), and Femoral cannula with introducer (K924642). b) The Cincinnati Sub-zero Hemothem 400 (KS11742). c) The Augustine Medical, Inc. Bair B u g g d Patient Warming System…	Medtronic Bio-Medicus, Inc.	1993	1
*	K811742	Hemotherm Model 400 Our reading of the summary gave K511742, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cincinnati Sub-zero Hemotherm 400”.	Cincinnati Sub-Zero	1981	2
Kept off the family tree	K573745	Bair Hugger Patient Warming System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K010338	Artic Sun Temperature Management System, Model 200	Medivance, Inc.	2001	1
*	K904404	Multi-Lumen Central Venous Catheter Set Summary page 1 …divance Artic SunTM Temperature Management System (KO1 0338). e) The Arrow International Fnc. Multi-Lumen Central Venous Catheter (K904404). 44 fj Thc Mallinckrodt Mon-a-ThermTMGeneral Purposc Temp…	Arrow Intl., Inc.	1991	—
*	K890484	HI-LO Temp General Purpose Temperature Probe Summary page 2 …s Catheter (K904404). 44 fj Thc Mallinckrodt Mon-a-ThermTMGeneral Purposc Temperature Probe (K890484) Tntended Use a, twqm&wc. The SetPoin@ System is indicated for use in cardiac surgery patients to achieve and/or mai…	Mallinckrodt Anesthesia Products	1989	—

Also cleared against K003724: 2 other devices →

What descends from it? (27)

See all 27

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022366	Celsius Control System	Innercool Therapies	2003	16
K030421	Alsius Coolgard 3000 & Alsius Catheter System	Alsius Corp.	2003	15
K023914	Coaxia Flocontrol Catheter	Coaxia, Inc.	2003	6
K033623	Celsius Control System	Innercool Therapies, Inc.	2004	2
K063405	Reprieve Endovascular Temperature Therapy System	Radiant Medical	2007	1
K024327	Setpoint Endovascular Temperature Probe	Radiant Medical	2003	1
K071358	Reprieve Endovascular Temperature Therapy System	Radiant Medical	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?

4 of the 7 ancestors have a recall of any class.
Of its descendants, K022366 (Innercool Therapies, 2003) has gone furthest, with 16 descendants of its own.
2 other devices also cite its predicate K003724.

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.

FDA decisions per year · NCX

1in 2023

2007high 6 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCX

204in 2016

2007high 204 (2016) · low 28 (2007)2026

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

Recalls per year · NCX

28in 2021

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

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

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 SetPoiiitO 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/K012512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012512: Setpoint Endovascular Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012512

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026