510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080908Substantially Equivalent

Innercool Therapies, Inc., Rapidblue System

Innercool Therapies, Inc.- A Delaware Corporation, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080908 is the FDA 510(k) clearance record for INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM, a class II device, cleared for Innercool Therapies, Inc.- A Delaware Corporation on under FDA product code NCX (System, Hypothermia, Intravenous, Cooling). FDA records list one 510(k) clearance for Innercool Therapies, Inc.- A Delaware Corporation. As of , FDA records show one recall naming K080908.

Clearance record

Decision date
Received
(199 days to decision)
Product code
NCX System, Hypothermia, Intravenous, Cooling
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Innercool Therapies, Inc.- A Delaware Corporation 6740 Top Gun St., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCX

Trailing 12 months

FDA records hold no clearances under product code NCX in the trailing twelve months.

FDA records show no clearances under product code NCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260