Cleared Traditional

K873699 - ECMO-TEMP (TM) BLOOD WARMING DEVICE

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

K873699 · Seabrook Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K873699.
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
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
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