AEROSOL MASKS, 81426, 81476, 81490 & 81492— 510(k) K913220

Name: FDA 510(k) clearance K913220
Creator: U.S. Food and Drug Administration
Published: 1991-10-10

Substantially Equivalent

Specialty Packaging Producs, Inc.

FDA 510(k) clearance K913220 for AEROSOL MASKS, 81426, 81476, 81490 & 81492, Substantially Equivalent on 1991-10-10. Applicant: Specialty Packaging Producs, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Packaging Producs, Inc.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1991-07-19
Decision date: 1991-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

More clearances from Specialty Packaging Producs, Inc.

view all

K922492 — SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER1992-08-24
K913163 — NON REBREATHING VALVE1992-02-03
K913422 — OXYGEN TUBING, 815031992-01-30
K913164 — NON REBREATHING MASK1992-01-15
K913216 — TRACH T ADAPTER1992-01-15

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.