Cleared Traditional

K900581 - DANNIFLEX CPM 880(TM) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K900581 · Buckman Co., Inc. · Physical Medicine device
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Feb 1990
Decision
13d
Days
Class 1
Risk

K900581 is an FDA 510(k) clearance for the DANNIFLEX CPM 880(TM). Classified as Exerciser, Finger, Powered (product code JFA), Class I - General Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on February 20, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5410 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K900581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date February 20, 1990
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JFA Exerciser, Finger, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5410
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.