Cleared Traditional

K960675 - WALKHALER PORTABLE COMPRESSOR MODEL 45F70

K960675 is an FDA 510(k) clearance for WALKHALER PORTABLE COMPRESSOR MODEL 45F70, manufactured by Pari Holding Co.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K960675 · Pari Holding Co. · Anesthesiology device
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May 1996
Decision
87d
Days
Class 2
Risk

K960675 is an FDA 510(k) clearance for the WALKHALER PORTABLE COMPRESSOR MODEL 45F70. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pari Holding Co. (Richmond, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 87 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 Pari Holding Co. devices

FDA 510(k) Submission Details - K960675

510(k) Number K960675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date May 17, 1996
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 248
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K960675.
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · Salter Labs · Jul 1996
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K955104 · Automatic Liquid Packaging, Inc. · Jun 1996
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
DEVILBISS MODEL 5500
K946095 · Devilbiss Health Care, Inc. · Aug 1995
3000 AEROSOL TWO
K943990 · Medical Industries America, Inc. · Mar 1995