Cleared Traditional

K801301 - GOLDEN THERMAL RHINOPLASTY CAST BANDAGE

K801301 is an FDA 510(k) clearance for GOLDEN THERMAL RHINOPLASTY CAST BANDAGE, manufactured by Auric, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801301 · Auric, Inc. · Physical Medicine device
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Jun 1980
Decision
17d
Days
Class 2
Risk

K801301 is an FDA 510(k) clearance for the GOLDEN THERMAL RHINOPLASTY CAST BANDAGE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Auric, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 17 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 - K801301

510(k) Number K801301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date June 20, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 116d · This submission: 17d
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 K801301.
MUL-T-PAD
K832819 · Gaymar Industries, Inc. · Sep 1983
MUL-T-BLANKET
K832820 · Gaymar Industries, Inc. · Sep 1983
HOT/ICE
K830757 · Thermo Temp, Inc. · Mar 1983
GELSKIN
K791162 · Spenco Medical Corp. · Sep 1979
THERA-PAK
K780452 · Hydro-Med Products, Inc. · Jun 1978
BAND-AGE ICE-BANDAGE
K761254 · Surgicot, Inc. · Feb 1977
K801301 · GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
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