510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122813Substantially Equivalent

Hemotherm Model 400Ce Cooler/heater System

Gentherm Medical, LLC, Sharonville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122813 is the FDA 510(k) clearance record for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, a class II device, cleared for Cincinnati Sub-Zero Products, Inc. on under FDA product code DWC (Controller, Temperature, Cardiopulmonary Bypass). FDA's definition for product code DWC reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 12 510(k) clearances for Gentherm Medical, LLC, from to . As of , FDA records show 6 recalls naming K122813.

Clearance record

Decision date
Received
(96 days to decision)
Product code
DWC Controller, Temperature, Cardiopulmonary Bypass
Regulation
21 CFR 870.4250
Device class
Class II
Review panel
Cardiovascular
Applicant
Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Rd., Sharonville OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWC

Trailing 12 months

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

FDA records show no clearances under product code DWC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWC, 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