SOF-TOUCH NASAL CANNULA CAT.#304 & 305— 510(k) K802062

Name: FDA 510(k) clearance K802062
Creator: U.S. Food and Drug Administration
Published: 1980-09-09

Substantially Equivalent

Hospitak, Inc.

FDA 510(k) clearance K802062 for SOF-TOUCH NASAL CANNULA CAT.#304 & 305, Substantially Equivalent on 1980-09-09. Applicant: Hospitak, Inc.. Device class: 1.

Clearance details

Applicant: Hospitak, Inc.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1980-08-27
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAT

view all

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

More clearances from Hospitak, Inc.

view all

K955483 — TRACH MASK MODEL (245, 246)1996-02-28
K954787 — ILLUMINATOR1996-01-31
K953619 — WARM N WET HME W/LUER ADAPTER1995-08-25
K953620 — WARM N WET HMEF W/LUER ADAPTER1995-08-25
K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER1994-11-30

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.