Cleared Traditional

K811164 - URETHANE ORTHOPAEDIC CASTING TAPE

K811164 is an FDA 510(k) clearance for URETHANE ORTHOPAEDIC CASTING TAPE, manufactured by Hexcel Medical. The device is a Class 1 Physical Medicine device with product code ITG cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K811164 · Hexcel Medical · Physical Medicine device
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May 1981
Decision
29d
Days
Class 1
Risk

K811164 is an FDA 510(k) clearance for the URETHANE ORTHOPAEDIC CASTING TAPE. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Hexcel Medical (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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 Hexcel Medical devices

FDA 510(k) Submission Details - K811164

510(k) Number K811164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 27, 1981
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

ITG Device Classification - Class 1, General Controls

Product Code ITG Bandage, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ITG Bandage, Cast

All 21
Devices cleared under the same product code (ITG) and FDA review panel - the closest regulatory comparables to K811164.
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · Zimmer, Inc. · Feb 1982
CARAFLEX ELASTIC POLYMER PLASTER BANDA
K813219 · Carapace, Inc. · Dec 1981
CRYSTONA
K811754 · Smith & Nephew, Inc. · Jul 1981
CELLONA PLASTER VARNISH
K810111 · Secol Co. · Feb 1981
CELLONA
K802792 · Secol Co. · Dec 1980
CELLAMIN
K802796 · Secol Co. · Nov 1980