Cleared Traditional

K920581 - POLAR PAD (STERILE)

K920581 is an FDA 510(k) clearance for POLAR PAD (STERILE), manufactured by Breg, Inc.. The device is a Class 2 Physical Medicine device with 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.

FDA 510(k) Submission Details - K920581

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 116d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K920581.
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K915196 · Hollister, Inc. · Feb 1992
TTU-100THERMAL THERAPY UNIT
K913026 · Danninger Medical Technology, Inc. · Dec 1991
POLAR PADS
K914434 · Breg, Inc. · Oct 1991
K920581 · POLAR PAD (STERILE)
Download PDF Breg, Inc.