Cleared Traditional

K800752 - PRE-PADDED PLASTER/PARIS BAND/SPLINTS

K800752 is the FDA 510(k) clearance for PRE-PADDED PLASTER/PARIS BAND/SPLINTS by Ortho-Care, Inc.. It is a Class 1 Physical Medicine device (product code ITG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K800752 · Ortho-Care, Inc. · Physical Medicine device
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Apr 1980
Decision
17d
Days
Class 1
Risk

K800752 is an FDA 510(k) clearance for the PRE-PADDED PLASTER/PARIS BAND/SPLINTS. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Ortho-Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 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 890.3025 - 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 Ortho-Care, Inc. devices

Submission Details

510(k) Number K800752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1980
Decision Date April 21, 1980
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K800752.
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
3M ORTHOPEDIC CASTING TAPE
K791094 · 3M Company · Jul 1979