Cleared Traditional

K883603 - SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

K883603 is an FDA 510(k) clearance for SARNS TEMP. CONTROL AND MONITOR SYSTEM ..., manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K883603 · 3M Health Care, Sarns · Cardiovascular device
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Nov 1988
Decision
72d
Days
Class 2
Risk

K883603 is an FDA 510(k) clearance for the SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II). Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on November 3, 1988 after a review of 72 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K883603

510(k) Number K883603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date November 03, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 16
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K883603.
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · Terumo Cardiovascular Systems Corp. · Nov 2007
STOCKERT HEATER-COOLER SYSTEM 3T
K052601 · Sorin Group Deutschland GmbH · Jun 2006
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
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
SARNS WARMER, PART #164975 AND #164980
K873813 · 3M Health Care, Sarns · Nov 1987