Cleared Traditional

K813219 - CARAFLEX ELASTIC POLYMER PLASTER BANDA

K813219 is an FDA 510(k) clearance for CARAFLEX ELASTIC POLYMER PLASTER BANDA, manufactured by Carapace, Inc.. The device is a Class 1 Physical Medicine device with product code ITG cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K813219 · Carapace, Inc. · Physical Medicine device
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Dec 1981
Decision
38d
Days
Class 1
Risk

K813219 is an FDA 510(k) clearance for the CARAFLEX ELASTIC POLYMER PLASTER BANDA. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Carapace, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1981 after a review of 38 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 Carapace, Inc. devices

FDA 510(k) Submission Details - K813219

510(k) Number K813219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1981
Decision Date December 17, 1981
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 15
Devices cleared under the same product code (ITG) and FDA review panel - the closest regulatory comparables to K813219.
SOFFBAN ORTHOPEDIC PADDING
K832992 · Smith & Nephew, Inc. · Nov 1983
ORTHOPEDIC CASTING TAPE MAXCAST
K832237 · Cutter Laboratories, Inc. · Aug 1983
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · Zimmer, Inc. · Feb 1982
CRYSTONA
K811754 · Smith & Nephew, Inc. · Jul 1981
PROCAST
K791831 · Medical Specialties, Inc. · Sep 1979
FELTLOC CAST PADDING
K791305 · Howmedica Corp. · Jul 1979