Cleared Traditional

K913734 - BAIR HUGGER PATIENT WARM SYST/BABY WARM...

K913734 is an FDA 510(k) clearance for BAIR HUGGER PATIENT WARM SYST/BABY WARM..., 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 64-day FDA review.

K913734 · Augustine Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1991
Decision
64d
Days
Class 2
Risk

K913734 is an FDA 510(k) clearance for the BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER. 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 October 23, 1991 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K913734

510(k) Number K913734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date October 23, 1991
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 K913734.
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
K920432 · Augustine Medical, Inc. · Jun 1992
BAIR HUGGER PATIENT WARMING SYSTEM
K920265 · Augustine Medical, Inc. · Mar 1992
TC-1000, TC-1050 SYSTEM
K914805 · Gaymar Industries, Inc. · Jan 1992
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
K912051 · Gaymar Industries, Inc. · Jul 1991
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K904690 · Marquest Medical Products, Inc. · Feb 1991
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
K903360 · Augustine Medical, Inc. · Aug 1990