Cleared Traditional

K962072 - PRONEB TURBO COMPRESSOR MODEL 38V0200

K962072 is an FDA 510(k) clearance for PRONEB TURBO COMPRESSOR MODEL 38V0200, 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 85-day FDA review.

K962072 · Pari Holding Co. · Anesthesiology device
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Aug 1996
Decision
85d
Days
Class 2
Risk

K962072 is an FDA 510(k) clearance for the PRONEB TURBO COMPRESSOR MODEL 38V0200. 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 August 21, 1996 after a review of 85 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 - K962072

510(k) Number K962072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date August 21, 1996
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K962072.
HEART NEBULIZER #100609
K963910 · Vortran Medical Technology 1, Inc. · Dec 1996
SALTERLABS 8660 SERIES NEBULIZER
K962879 · Salter Labs · Oct 1996
SALTER LABS 8990 SERIES NEBULIZER
K962085 · Salter Labs · Aug 1996
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