Cleared Traditional

K960167 - SYSTEM

K960167 is an FDA 510(k) clearance for SYSTEM, manufactured by Augustine Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K960167 · Augustine Medical, Inc. · Cardiovascular device
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Jun 1996
Decision
153d
Days
Class 2
Risk

K960167 is an FDA 510(k) clearance for the SYSTEM, THERMAL REGULATING 74-DWJ. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 17, 1996 after a review of 153 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 Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K960167

510(k) Number K960167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date June 17, 1996
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
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 63
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K960167.
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
K001149 · Augustine Medical, Inc. · Sep 2000
CONTOR TABLE SURFACE
K973705 · Hill-Rom, Inc. · Aug 1998
BAIR HUGGER MODEL 630 CARDIAC BLANKET
K964673 · Augustine Medical, Inc. · Jun 1997
BAIR HUGGER MODEL 655 BLANKET
K952864 · Augustine Medical, Inc. · Sep 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
K950416 · Augustine Medical, Inc. · Aug 1995
TC 3000
K942881 · Gaymar Industries, Inc. · May 1995