Cleared Traditional

K800752 - PRE-PADDED PLASTER/PARIS BAND/SPLINTS

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

K800752 · Ortho-Care, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K800752

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
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.

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.

K800752 · PRE-PADDED PLASTER/PARIS BAND/SPLINTS
Download PDF Ortho-Care, Inc.