Cleared Traditional

K761254 - BAND-AGE ICE-BANDAGE

K761254 is an FDA 510(k) clearance for BAND-AGE ICE-BANDAGE, manufactured by Surgicot, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K761254 · Surgicot, Inc. · Physical Medicine device
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Feb 1977
Decision
73d
Days
Class 2
Risk

K761254 is an FDA 510(k) clearance for the BAND-AGE ICE-BANDAGE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Surgicot, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1977 after a review of 73 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 Surgicot, Inc. devices

FDA 510(k) Submission Details - K761254

510(k) Number K761254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1976
Decision Date February 24, 1977
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 30
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K761254.
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255 · Concept, Inc. · Nov 1988
MUL-T-PAD
K832819 · Gaymar Industries, Inc. · Sep 1983
MUL-T-BLANKET
K832820 · Gaymar Industries, Inc. · Sep 1983
TECNOL PATIENT USE ICE PACK
K760782 · Tecnol New Jersey Wound Care, Inc. · Dec 1976
T-PUMP, TEMPERATURE - THERAPY PUMP
K760804 · Gaymar Industries, Inc. · Oct 1976
T-PAD
K760527 · Gaymar Industries, Inc. · Sep 1976