Cleared Traditional

K913016 - WARMTOUCH

K913016 is the FDA 510(k) clearance for WARMTOUCH by Advanced Warming Systems, Inc.. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K913016 · Advanced Warming Systems, Inc. · Cardiovascular device
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Sep 1991
Decision
65d
Days
Class 2
Risk

K913016 is an FDA 510(k) clearance for the WARMTOUCH. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Advanced Warming Systems, Inc. (Lubbock, US). The FDA issued a Cleared decision on September 4, 1991 after a review of 65 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 Advanced Warming Systems, Inc. devices

Submission Details

510(k) Number K913016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date September 04, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
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 35
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K913016.
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
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COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
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KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
K033021 · Kimberly-Clark Corp. · Nov 2003
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990
RK2000 K-THERMIA SYSTEM
K882442 · Baxter Healthcare Corp · Sep 1988
HEART-CHILL SALINE SLUSH PAD
K882035 · Buckman Co., Inc. · Jul 1988