Cleared Traditional

MODEL Q55XT POWERED TREADMILL (K864013) - FDA 510(k) Clearance

Class I Physical Medicine device.

K864013 · Quinton, Inc. · Physical Medicine device
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Nov 1986
Decision
30d
Days
Class 1
Risk

K864013 is an FDA 510(k) clearance for the MODEL Q55XT POWERED TREADMILL. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on November 14, 1986 after a review of 30 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 Quinton, Inc. devices

Submission Details

510(k) Number K864013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date November 14, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOL Treadmill, 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.

Regulatory Peers - IOL Treadmill, Powered

All 9
Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K864013.
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K904556 · Boston Scientific Corp · Dec 1991
MEDTRACK TREADMILL
K911751 · Quinton, Inc. · May 1991
MODIFIED Q-SERIES OF TREADMILLS
K885062 · Quinton, Inc. · Dec 1988
MODIFIED Q50 MEDICAL TREADMILL
K863299 · Quinton, Inc. · Sep 1986
Q50 MEDICAL TREADMILL
K862741 · Quinton, Inc. · Jul 1986
PROGRAM. TREADMILL CONTROLLER #645
K830146 · Quinton, Inc. · Feb 1983