Cleared Traditional

MICROTRAK EIA AUTOWASHER (K891269) - FDA 510(k) Clearance

Class I Microbiology device.

K891269 · Syva Co. · Microbiology device
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May 1989
Decision
53d
Days
Class 1
Risk

K891269 is an FDA 510(k) clearance for the MICROTRAK EIA AUTOWASHER. Classified as Cannula, Ear (product code JYC), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 878.4800 - the FDA microbiology 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 Syva Co. devices

Submission Details

510(k) Number K891269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1989
Decision Date May 01, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 102d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JYC Cannula, Ear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.