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Aerosol Masks 81426, 81476, 81490 & 81492

by Specialty Packaging Producs, Inc.

510(k) K913220

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913220 Date10 Oct 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Aerosol Masks are medical devices designed for aerosol delivery therapy. These masks are available in multiple model numbers including 81426, 81476, 81490, and 81492. They are intended for use in medical settings to administer aerosolized medications to patients.

The masks are supplied in disposable individual packaging and are latex-free. They are designed for single patient use with multiple applications. The device has FDA 510(k) clearance with product code CAF and is classified under the Anesthesiology advisory committee.

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