Cleared Traditional

K920581 - POLAR PAD (STERILE)

K920581 is the FDA 510(k) clearance for POLAR PAD (STERILE) by Breg, Inc.. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K920581 · Breg, Inc. · Physical Medicine device
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Mar 1992
Decision
39d
Days
Class 2
Risk

K920581 is an FDA 510(k) clearance for the POLAR PAD (STERILE). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Breg, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - the FDA physical medicine device 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 Breg, Inc. devices

Submission Details

510(k) Number K920581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date March 20, 1992
Days to Decision 39 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 18
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K920581.
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
SUR FLO THERMAL THERAPY PADS
K930634 · Buckman Co., Inc. · Nov 1993
MEDICOOL
K923643 · Micromedic Systems · Mar 1993
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · Baxter Healthcare Corp · Feb 1991