Cleared Traditional

K962534 - THERA-MIST NEBULIZER MODEL-P3000

K962534 is an FDA 510(k) clearance for THERA-MIST NEBULIZER MODEL-P3000, manufactured by Pegasus Research Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K962534 · Pegasus Research Corp. · Anesthesiology device
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Feb 1997
Decision
245d
Days
Class 2
Risk

K962534 is an FDA 510(k) clearance for the THERA-MIST NEBULIZER MODEL-P3000. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 245 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.

FDA 510(k) Submission Details - K962534

510(k) Number K962534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date February 28, 1997
Days to Decision 245 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
105d slower than avg
Panel avg: 140d · This submission: 245d
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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K962534.
FPT NEBULIZER
K970010 · Fluid Propulsion Technologies, Inc. · Apr 1997
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
K970035 · Graham-Field, Inc. · Apr 1997
THE SWIRLER NEBULIZER
K952910 · Amici, Inc. · Mar 1997
RESPIFLO
K962872 · Tyco Healthcare Deutschaland GmbH · Feb 1997
RESPIFLO/S
K962874 · Curtin & Associates International , Inc. · Feb 1997
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
K963917 · Holden Walker Corp. · Feb 1997