Cleared Traditional

K902502 - BYRD STAINLESS STEEL DILATOR

K902502 is an FDA 510(k) clearance for BYRD STAINLESS STEEL DILATOR, manufactured by Medical Engineering and Development Institute. The device is a Class 1 General & Plastic Surgery device with product code GCC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K902502 · Medical Engineering and Development Institute · General & Plastic Surgery device
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Aug 1990
Decision
63d
Days
Class 1
Risk

K902502 is an FDA 510(k) clearance for the BYRD STAINLESS STEEL DILATOR. Classified as Dilator, Catheter (product code GCC), Class I - General Controls.

Submitted by Medical Engineering and Development Institute (West Lafayette, US). The FDA issued a Cleared decision on August 7, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Medical Engineering and Development Institute devices

FDA 510(k) Submission Details - K902502

510(k) Number K902502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date August 07, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

GCC Device Classification - Class 1, General Controls

Product Code GCC Dilator, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.