Cleared Traditional

K914434 - POLAR PADS

K914434 is an FDA 510(k) clearance for POLAR PADS, 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 20-day FDA review.

K914434 · Breg, Inc. · Physical Medicine device
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Oct 1991
Decision
20d
Days
Class 2
Risk

K914434 is an FDA 510(k) clearance for the POLAR PADS. 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 October 24, 1991 after a review of 20 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 - K914434

510(k) Number K914434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date October 24, 1991
Days to Decision 20 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
96d faster than avg
Panel avg: 116d · This submission: 20d
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 K914434.
POLAR PAD (STERILE)
K920581 · Breg, Inc. · Mar 1992
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
TTU-100THERMAL THERAPY UNIT
K913026 · Danninger Medical Technology, Inc. · Dec 1991
POLAR PUMP, MODEL 500
K913729 · Breg, Inc. · Oct 1991
GOLDEN THERMAL(R)
K914182 · Seabrook Medical Systems, Inc. · Oct 1991
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
K914434 · POLAR PADS
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