Cleared Traditional

K920091 - IOWA ORAL PERFORMANCE ISNTRUMENT

K920091 is an FDA 510(k) clearance for IOWA ORAL PERFORMANCE ISNTRUMENT, manufactured by Breakthrough, Inc.. The device is a Class 1 Physical Medicine device with product code IKE cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K920091 · Breakthrough, Inc. · Physical Medicine device
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May 1992
Decision
133d
Days
Class 1
Risk

K920091 is an FDA 510(k) clearance for the IOWA ORAL PERFORMANCE ISNTRUMENT. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Breakthrough, Inc. (Oakdale, US). The FDA issued a Cleared decision on May 20, 1992 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1615 - 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 Breakthrough, Inc. devices

FDA 510(k) Submission Details - K920091

510(k) Number K920091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date May 20, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

IKE Device Classification - Class 1, General Controls

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
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.