Cleared Traditional

K873699 - ECMO-TEMP (TM) BLOOD WARMING DEVICE

K873699 is an FDA 510(k) clearance for ECMO-TEMP (TM) BLOOD WARMING DEVICE, manufactured by Seabrook Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K873699 · Seabrook Medical Systems, Inc. · Cardiovascular device
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Dec 1987
Decision
97d
Days
Class 2
Risk

K873699 is an FDA 510(k) clearance for the ECMO-TEMP (TM) BLOOD WARMING DEVICE. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Seabrook Medical Systems, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Seabrook Medical Systems, Inc. devices

FDA 510(k) Submission Details - K873699

510(k) Number K873699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1987
Decision Date December 22, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K873699.
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
SARNS WARMER, PART #164975 AND #164980
K873813 · 3M Health Care, Sarns · Nov 1987
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677 · Gambro, Inc. · Jul 1983
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · Gambro, Inc. · Oct 1982