Cleared Traditional

K946196 - TROPICAIR CONVECTIVE WARING SYSTEM

K946196 is the FDA 510(k) clearance for TROPICAIR CONVECTIVE WARING SYSTEM by Seabrook Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K946196 · Seabrook Medical Systems, Inc. · Cardiovascular device
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Sep 1995
Decision
260d
Days
Class 2
Risk

K946196 is an FDA 510(k) clearance for the TROPICAIR CONVECTIVE WARING SYSTEM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Seabrook Medical Systems, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 260 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - 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 K946196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date September 06, 1995
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
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 - DWJ System, Thermal Regulating

All 43
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K946196.
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · Nellcor Puritan Bennett, Inc. · Apr 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · Nellcor Puritan Bennett, Inc. · Jan 2002
CONTOR TABLE SURFACE
K973705 · Hill-Rom, Inc. · Aug 1998
WARMTOUCH PLASTIC WARMING COVER
K943276 · Mallinckrodt Medical · Sep 1994
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM
K940171 · Cabot Medical Corp. · Mar 1994
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990