Cleared Traditional

K970367 - THERMO-STAT SYSTEM

K970367 is an FDA 510(k) clearance for THERMO-STAT SYSTEM, manufactured by Aquarius Medical Corp.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K970367 · Aquarius Medical Corp. · Cardiovascular device
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Dec 1997
Decision
320d
Days
Class 2
Risk

K970367 is an FDA 510(k) clearance for the THERMO-STAT SYSTEM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Aquarius Medical Corp. (Scottsdale, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aquarius Medical Corp. devices

FDA 510(k) Submission Details - K970367

510(k) Number K970367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date December 17, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K970367.
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
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CONTOR TABLE SURFACE
K973705 · Hill-Rom, Inc. · Aug 1998
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K964673 · Augustine Medical, Inc. · Jun 1997
THERMAL REGULATION SYSTEM BLANKET
K964377 · Gibeck, Inc. · Apr 1997
SYSTEM, THERMAL REGULATING 74-DWJ
K960167 · Augustine Medical, Inc. · Jun 1996