Cleared Traditional

K943276 - WARMTOUCH PLASTIC WARMING COVER

K943276 is the FDA 510(k) clearance for WARMTOUCH PLASTIC WARMING COVER by Mallinckrodt Medical. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K943276 · Mallinckrodt Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
74d
Days
Class 2
Risk

K943276 is an FDA 510(k) clearance for the WARMTOUCH PLASTIC WARMING COVER. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 74 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 Mallinckrodt Medical devices

Submission Details

510(k) Number K943276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date September 19, 1994
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
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 45
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K943276.
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · Nellcor Puritan Bennett, Inc. · Apr 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · Nellcor Puritan Bennett, Inc. · Jan 2002
CONTOR TABLE SURFACE
K973705 · Hill-Rom, Inc. · Aug 1998
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM
K940171 · Cabot Medical Corp. · Mar 1994
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K904690 · Marquest Medical Products, Inc. · Feb 1991
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990