Cleared Traditional

K913220 - AEROSOL MASKS, 81426, 81476, 81490 & 81492

K913220 is an FDA 510(k) clearance for AEROSOL MASKS, manufactured by Specialty Packaging Producs, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K913220 · Specialty Packaging Producs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
83d
Days
Class 2
Risk

K913220 is an FDA 510(k) clearance for the AEROSOL MASKS, 81426, 81476, 81490 & 81492. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on October 10, 1991 after a review of 83 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 Specialty Packaging Producs, Inc. devices

FDA 510(k) Submission Details - K913220

510(k) Number K913220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1991
Decision Date October 10, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
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 397
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K913220.
DEVILBISS MODEL 7427D
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RHINO-GUARD
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K913000 · B&B Medical Technologies, Inc. · Aug 1991