THE COMFORTABLE CANNULA— 510(k) K896036

Name: FDA 510(k) clearance K896036
Creator: U.S. Food and Drug Administration
Published: 1989-11-17

Substantially Equivalent

Comfortable Concepts Corp.

FDA 510(k) clearance K896036 for THE COMFORTABLE CANNULA, Substantially Equivalent on 1989-11-17. Applicant: Comfortable Concepts Corp.. Device class: 1.

Clearance details

Applicant: Comfortable Concepts Corp.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1989-10-17
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copiague, NY, US

Download summary PDF View on FDA.gov ↗

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K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI2001-06-13
K935533 — NASAL CANNULA1994-02-03
K922397 — 4 SURE TM NASAL OXYGEN CANNULA1993-03-18
K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
K920573 — CANNULA NASAL OXYGEN1992-08-11

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.