Cleared Traditional

FPL (K915897) - FDA 510(k) Clearance

Class I Physical Medicine device.

K915897 · Wrm Computers · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.