Cleared Traditional

K771539 - STEPPER

K771539 is an FDA 510(k) clearance for STEPPER, manufactured by Tridak. The device is a Class 1 General Hospital device with product code KYX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K771539 · Tridak · General Hospital
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Oct 1977
Decision
57d
Days
Class 1
Risk

K771539 is an FDA 510(k) clearance for the STEPPER. Classified as Dispenser, Liquid Medication (product code KYX), Class I - General Controls.

Submitted by Tridak (Mchenry, US). The FDA issued a Cleared decision on October 7, 1977 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6430 - the FDA general hospital 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.

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FDA 510(k) Submission Details - K771539

510(k) Number K771539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1977
Decision Date October 07, 1977
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

KYX Device Classification - Class 1, General Controls

Product Code KYX Dispenser, Liquid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6430
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.