Cleared Traditional

PM (K925980) - FDA 510(k) Clearance

Class I Physical Medicine device.

K925980 · Pathfinder Intl. Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
119d
Days
Class 1
Risk

K925980 is an FDA 510(k) clearance for the PM. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Pathfinder Intl. Corp. (Gainesville, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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 Pathfinder Intl. Corp. devices

Submission Details

510(k) Number K925980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date March 24, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 63
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K925980.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · Fred Sammons, Inc. · Jan 1982
DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · Fred Sammons, Inc. · Sep 1981