Cleared Traditional

MYA-1 AND MYT-1 MYELOGRAM TRAY (K870418) - FDA 510(k) Clearance

K870418 · North Coast Medi-Tek · Cardiovascular device
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Mar 1987
Decision
42d
Days
-
Risk

K870418 is an FDA 510(k) clearance for the MYA-1 AND MYT-1 MYELOGRAM TRAY.

Submitted by North Coast Medi-Tek (Mentor, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 North Coast Medi-Tek devices

Submission Details

510(k) Number K870418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date March 17, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -