Cleared Traditional

K830650 - SUPPORT PRODUCTS EXAMPLE PROSET CAST

K830650 is an FDA 510(k) clearance for SUPPORT PRODUCTS EXAMPLE PROSET CAST, manufactured by Isopedix Corp.. The device is a Class 1 Physical Medicine device with product code ITG cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K830650

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.

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 K830650.
NON WETTING UNDERCAST PADDING
K833732 · American Medical Disposable, Inc. · Dec 1983
SOFFBAN ORTHOPEDIC PADDING
K832992 · Smith & Nephew, Inc. · Nov 1983
ORTHOPEDIC CASTING TAPE MAXCAST
K832237 · Cutter Laboratories, Inc. · Aug 1983
WEBRIL CAST PADDING
K820140 · Stan-Pak Ent. · Feb 1982
SPECIALIST CAST PADDING
K820155 · Stan-Pak Ent. · Feb 1982
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · Zimmer, Inc. · Feb 1982