Cleared Traditional

K874884 - MEDTRONIC(R) ORTHOFLEX(TM) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K874884 · Metronic, Inc. · Physical Medicine device
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Jan 1988
Decision
58d
Days
Class 1
Risk

K874884 is an FDA 510(k) clearance for the MEDTRONIC(R) ORTHOFLEX(TM). Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Metronic, Inc. devices

Submission Details

510(k) Number K874884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date January 28, 1988
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.