Cleared Traditional

K896393 - CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620

K896393 is an FDA 510(k) clearance for CARDIAC COOLING JACKED, manufactured by Daily Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896393 · Daily Medical, Inc. · Cardiovascular device
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Feb 1990
Decision
88d
Days
Class 2
Risk

K896393 is an FDA 510(k) clearance for the CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Daily Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Daily Medical, Inc. devices

FDA 510(k) Submission Details - K896393

510(k) Number K896393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 02, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWC Device Classification - Class 2, Special Controls

Product Code DWC Controller, Temperature, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4250
Definition 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 Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWC Controller, Temperature, Cardiopulmonary Bypass

All 19
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K896393.
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
ORIGEN BLADDER HOLDER
K003145 · Origen Biomedical, Inc. · Apr 2001
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · Alpha Omega, Inc. · Nov 2000
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · 3M Health Care, Sarns · Nov 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · Buckman Co., Inc. · Feb 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · Pioneering Technologies, Inc. · Jan 1988