Cleared Traditional

K926455 - PARI FILTER/VALVE SET

K926455 is an FDA 510(k) clearance for PARI FILTER/VALVE SET, manufactured by Paul Ritzau Pari-Werk GmbH. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K926455

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
Combination Product No
PCCP Authorized No
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.

CAF Device Classification - Class 2, Special Controls

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 433
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K926455.
VENTI-GENTLE-HALER(TM)
K933915 · Vortran Medical Technology 1, Inc. · Oct 1993
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K923559 · Concord/Portex · Oct 1993
MICRO MIST(TM) NEBULIZER
K930525 · Hudson Respiratory Care, Inc. · Sep 1993
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
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ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO
K926301 · Dhd Diemolding Healthcare Div. · Jul 1993
PROMENADE
K930947 · Mada Medical Products, Inc. · Jun 1993