510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031544Substantially Equivalent

Heater Cooler Unit, Model Hcu 30

Jostra AG, The Woodlands TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031544 is the FDA 510(k) clearance record for HEATER COOLER UNIT, MODEL HCU 30, a class II device, cleared for Jostra AB 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 14 510(k) clearances for Jostra AB, from to . As of , FDA records show 4 recalls naming K031544.

Clearance record

Decision date
Received
(83 days to decision)
Product code
DWC Controller, Temperature, Cardiopulmonary Bypass
Regulation
21 CFR 870.4250
Device class
Class II
Review panel
Cardiovascular
Applicant
Jostra AB 2828 N. Crescent Ridge Dr., The Woodlands TX
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