Cleared Traditional

K120081 - NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

K120081 is an FDA 510(k) clearance for NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDI..., manufactured by Cincinnati Sub-Zero Products, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K120081 · 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
Feb 2012
Decision
37d
Days
Class 2
Risk

K120081 is an FDA 510(k) clearance for the NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS. 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 February 17, 2012 after a review of 37 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.

FDA 510(k) Submission Details - K120081

510(k) Number K120081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2012
Decision Date February 17, 2012
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 138
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K120081.
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
K121720 · Welkins, LLC · Aug 2012
HYBRID ARCTICGEL PAD
K120849 · Medivance, Inc. · Jul 2012
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
K121669 · Cincinnati Sub-Zero Products, Inc. · Jul 2012
HOTDOG PATIENT WARMING SYSTEM
K112488 · Augustine Biomedical & Design, LLC · Nov 2011
SIROCCO THERMAL REGULATING SYSTEM
K102856 · Galmaz Biotech S.L. · Jun 2011
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
K110104 · Cincinnati Sub-Zero Products, Inc. · Feb 2011