Cleared Traditional

K894555 - PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (FDA 510(k) Clearance)

Class I Anesthesiology device.

K894555 · Dura Pharmaceuticals, Inc. · Anesthesiology device
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Jan 1990
Decision
188d
Days
Class 1
Risk

K894555 is an FDA 510(k) clearance for the PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Dura Pharmaceuticals, Inc. (Ramona, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 188 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dura Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K894555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date January 24, 1990
Days to Decision 188 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 139d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
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.