Cleared Traditional

K964673 - BAIR HUGGER MODEL 630 CARDIAC BLANKET

K964673 is an FDA 510(k) clearance for BAIR HUGGER MODEL 630 CARDIAC BLANKET, 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 217-day FDA review.

K964673 · Augustine Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
217d
Days
Class 2
Risk

K964673 is an FDA 510(k) clearance for the BAIR HUGGER MODEL 630 CARDIAC BLANKET. 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 26, 1997 after a review of 217 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 - K964673

510(k) Number K964673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date June 26, 1997
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K964673.
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · Nellcor Puritan Bennett, Inc. · Jan 2002
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
SYSTEM, THERMAL REGULATING 74-DWJ
K960167 · Augustine Medical, Inc. · Jun 1996
BAIR HUGGER MODEL 655 BLANKET
K952864 · Augustine Medical, Inc. · Sep 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
K950416 · Augustine Medical, Inc. · Aug 1995