Cleared Special

K014121 - WARMTOUCH CARDIAC BLANKET

K014121 is an FDA 510(k) clearance for WARMTOUCH CARDIAC BLANKET, manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 25-day FDA review.

K014121 · Nellcor Puritan Bennett, Inc. · Cardiovascular device
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Jan 2002
Decision
25d
Days
Class 2
Risk

K014121 is an FDA 510(k) clearance for the WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 11, 2002 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K014121

510(k) Number K014121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2001
Decision Date January 11, 2002
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K014121.
CHILLBUSTER
K022903 · Microtek Medical, Inc. · Nov 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · Augustine Medical, Inc. · Jul 2002
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · Nellcor Puritan Bennett, Inc. · Apr 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
BAIR HUGGER MODEL 630 CARDIAC BLANKET
K964673 · Augustine Medical, Inc. · Jun 1997