Cleared Traditional

K926455 - PARI FILTER/VALVE SET

K926455 is the FDA 510(k) clearance for PARI FILTER/VALVE SET by Paul Ritzau Pari-Werk GmbH. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K926455 · Paul Ritzau Pari-Werk GmbH · Anesthesiology device
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Sep 1993
Decision
278d
Days
Class 2
Risk

K926455 is an FDA 510(k) clearance for the PARI FILTER/VALVE SET. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Paul Ritzau Pari-Werk GmbH (Richmond, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 278 days - an extended review 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: 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 Paul Ritzau Pari-Werk GmbH devices

Submission Details

510(k) Number K926455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date September 28, 1993
Days to Decision 278 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 140d · This submission: 278d
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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K926455.
MODEL IRC 1199 SCOUT NEBULIZER
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MISTY OX TURBOHEATER
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K962161 · Baxter Healthcare Corp · Aug 1996
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988