Cleared Special

K121669 - WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)

K121669 is an FDA 510(k) clearance for WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (..., manufactured by Cincinnati Sub-Zero Products, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 27-day FDA review.

K121669 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
27d
Days
Class 2
Risk

K121669 is an FDA 510(k) clearance for the WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS). Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on July 3, 2012 after a review of 27 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.

FDA 510(k) Submission Details - K121669

510(k) Number K121669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2012
Decision Date July 03, 2012
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 138
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K121669.
PINTLER PATIENT WARMING SYSTEM
K113705 · Pintler Medical · Aug 2012
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
K121720 · Welkins, LLC · Aug 2012
HYBRID ARCTICGEL PAD
K120849 · Medivance, Inc. · Jul 2012
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · Cincinnati Sub-Zero Products, Inc. · Feb 2012
HOTDOG PATIENT WARMING SYSTEM
K112488 · Augustine Biomedical & Design, LLC · Nov 2011
SIROCCO THERMAL REGULATING SYSTEM
K102856 · Galmaz Biotech S.L. · Jun 2011