Cleared Traditional

K020932 - DEVILBISS PULMO-AIDE COMPACT COMPRESSOR

K020932 is an FDA 510(k) clearance for DEVILBISS PULMO-AIDE COMPACT COMPRESSOR, manufactured by Sunrise Medical. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K020932 · Sunrise Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
98d
Days
Class 2
Risk

K020932 is an FDA 510(k) clearance for the DEVILBISS PULMO-AIDE COMPACT COMPRESSOR. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on June 28, 2002 after a review of 98 days - within the typical 510(k) review window.

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 - K020932

510(k) Number K020932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date June 28, 2002
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 440
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K020932.
GALEMED NEB-EASY NEBULIZER
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800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
K021175 · Aerogen, Inc. · May 2002
VORTEX VALVED HOLDING CHAMBER
K020944 · Pari Innovative Manufacturers, Inc. · May 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002