Cleared Traditional

K915897 - FPL

K915897 is an FDA 510(k) clearance for FPL, manufactured by Wrm Computers. The device is a Class 1 Physical Medicine device with product code IKE cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K915897 · Wrm Computers · Physical Medicine device
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Apr 1992
Decision
134d
Days
Class 1
Risk

K915897 is an FDA 510(k) clearance for the FPL. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Wrm Computers (Holland, HN). The FDA issued a Cleared decision on April 7, 1992 after a review of 134 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 Wrm Computers devices

FDA 510(k) Submission Details - K915897

510(k) Number K915897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date April 07, 1992
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
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.