INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM— 510(k) K080908

Clearance details

Applicant

Innercool Therapies, Inc.- A Delaware Corporation

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2008-04-01

Decision date

2008-10-17

Decision

Substantially Equivalent

Clearance type

Special

Location

San Diego, CA, US

• K223746 — 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 Console2023-01-13
• K220008 — 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 Console2022-06-02
• K213031 — 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 Console2021-12-20
• K152946 — TEMPEDY2016-09-15
• K153162 — Hypocore2016-05-24

Death

30

Malfunction

2,302

Total

2,332

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0845-2014 — InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908Class II·Terminated·Philips Healthcare·20140113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080908.