Cleared Traditional

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (K890997) - FDA 510(k) Clearance

Class I Chemistry device.

K890997 · Atlantic Wholesale, Inc. · Chemistry device
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Mar 1989
Decision
29d
Days
Class 1
Risk

K890997 is an FDA 510(k) clearance for the ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC). Classified as Resins, Ion-exchange (product code KEA), Class I - General Controls.

Submitted by Atlantic Wholesale, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 28, 1989 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2230 - the FDA in vitro diagnostics and chemistry 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 Atlantic Wholesale, Inc. devices

Submission Details

510(k) Number K890997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date March 28, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEA Resins, Ion-exchange
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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.