Cleared Traditional

K896984 - PARI I.S.-2

K896984 is the FDA 510(k) clearance for PARI I.S.-2 by Dura Pharmaceuticals, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896984 · Dura Pharmaceuticals, Inc. · Anesthesiology device
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Mar 1990
Decision
88d
Days
Class 2
Risk

K896984 is an FDA 510(k) clearance for the PARI I.S.-2. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Dura Pharmaceuticals, Inc. (Ramona, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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: 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 Dura Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K896984 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 11, 1989
Decision Date March 09, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 94
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MISTY OX TURBOHEATER
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