NASAL OXYGEN CANNULA, 81585, 81587 & 81589— 510(k) K913421

Name: FDA 510(k) clearance K913421
Creator: U.S. Food and Drug Administration
Published: 1991-10-18

Substantially Equivalent

Specialty Packaging Producs, Inc.

FDA 510(k) clearance K913421 for NASAL OXYGEN CANNULA, 81585, 81587 & 81589, Substantially Equivalent on 1991-10-18. Applicant: Specialty Packaging Producs, Inc.. Device class: 1.

Clearance details

Applicant: Specialty Packaging Producs, Inc.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1991-07-31
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

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K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
K920573 — CANNULA NASAL OXYGEN1992-08-11

More clearances from Specialty Packaging Producs, Inc.

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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 CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.