Cleared Traditional

SUPPORT PRODUCTS EXAMPLE PROSET CAST (K830650) - FDA 510(k) Clearance

Class I Physical Medicine device.

K830650 · Isopedix Corp. · Physical Medicine device
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Jul 1983
Decision
126d
Days
Class 1
Risk

K830650 is an FDA 510(k) clearance for the SUPPORT PRODUCTS EXAMPLE PROSET CAST. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Isopedix Corp. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Isopedix Corp. devices

Submission Details

510(k) Number K830650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1983
Decision Date July 07, 1983
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 36
Devices cleared under the same product code (ITG) and FDA review panel - the closest regulatory comparables to K830650.
SOFFBAN ORTHOPEDIC PADDING
K832992 · Smith & Nephew, Inc. · Nov 1983
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · Zimmer, Inc. · Feb 1982
CRYSTONA
K811754 · Smith & Nephew, Inc. · Jul 1981
FELTLOC CAST PADDING
K791305 · Howmedica Corp. · Jul 1979
3M ORTHOPEDIC CASTING TAPE
K791094 · 3M Company · Jul 1979
DELTA-LITE
K790320 · Johnson & Johnson Professionals, Inc. · May 1979