FDA product code NCX: System, Hypothermia, Intravenous, Cooling
NCX is the FDA product code for system, hypothermia, intravenous, cooling. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Neurology panel. FDA has cleared 26 510(k) submissions under NCX, 2 in the last five years, from 10 different applicants. The average 510(k) review took 145 days (median 110). FDA has posted 35 recalls for NCX devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Hypothermia, Intravenous, Cooling |
| Device class | Class II |
| Regulation | 21 CFR 870.5900 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 90 |
| 2022 | 1 | 149 |
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every NCX clearance
Top NCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alsius Corp. | 9 | 2008-08-13 |
| Zoll Circulation, Inc. | 5 | 2023-01-13 |
| Radiant Medical | 4 | 2007-06-01 |
| Zoll Circulation | 2 | 2014-10-03 |
| Seiratherm GmbH | 1 | 2016-09-15 |
5 more applicants have NCX clearances. See the full list in Caduvo.
Most recent NCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223746 | Zoll Circulation, Inc. | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console | 2023-01-13 | 30 |
| K220008 | Zoll Circulation, Inc. | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console | 2022-06-02 | 149 |
| K213031 | Zoll Circulation, Inc. | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console | 2021-12-20 | 90 |
| K152946 | Seiratherm GmbH | TEMPEDY | 2016-09-15 | 345 |
| K153162 | Novocor Medical Systems, Inc. | Hypocore | 2016-05-24 | 204 |
Recalls for NCX devices
35 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-06.
| Year | Recalls |
|---|---|
| 2021 | 28 |
Frequently asked questions
What is FDA product code NCX?
NCX is the FDA product code for system, hypothermia, intravenous, cooling. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Neurology panel.
What device class is NCX?
Class II, regulation 21 CFR 870.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCX?
Across 26 cleared submissions the average was 145 days from receipt to decision (median 110).
Which companies have the most NCX clearances?
Alsius Corp. (9); Zoll Circulation, Inc. (5); Radiant Medical (4); Zoll Circulation (2); Seiratherm GmbH (1).
Have NCX devices been recalled?
Yes: 35 product recalls across 7 recall events; the most recent began 2021-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NCX
- Run a recall and safety report across every NCX manufacturer
- Watch product code NCX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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