Cleared Traditional

K903480 - HANN-VAC TM, DISPOSABLE,SUCTION CATHETER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K903480 · Un-I-Med, Inc. · Anesthesiology device
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Oct 1991
Decision
425d
Days
Class 1
Risk

K903480 is an FDA 510(k) clearance for the HANN-VAC TM, DISPOSABLE,SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Un-I-Med, Inc. (Murray, US). The FDA issued a Cleared decision on October 1, 1991 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Un-I-Med, Inc. devices

Submission Details

510(k) Number K903480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1990
Decision Date October 01, 1991
Days to Decision 425 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 139d · This submission: 425d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.