Cleared Traditional

K802062 - SOF-TOUCH NASAL CANNULA CAT.#304 & 305

K802062 is an FDA 510(k) clearance for SOF-TOUCH NASAL CANNULA CAT.#304 & 305, manufactured by Hospitak, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K802062 · Hospitak, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
13d
Days
Class 1
Risk

K802062 is an FDA 510(k) clearance for the SOF-TOUCH NASAL CANNULA CAT.#304 & 305. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospitak, Inc. devices

FDA 510(k) Submission Details - K802062

510(k) Number K802062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1980
Decision Date September 09, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

CAT Device Classification - Class 1, General Controls

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAT Cannula, Nasal, Oxygen

All 14
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K802062.
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · Salter Labs · Sep 1986
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · Conphar, Inc. · Jul 1979
NASAL, OXYGEN, CANNULA
K790885 · Airlife, Inc. · May 1979
CANNULAS, DYNACOR'S NASAL OXYGEN
K790056 · Medline Industries, Inc. · Feb 1979