Cleared Traditional

K810342 - NASAL CANNULA

K810342 is an FDA 510(k) clearance for NASAL CANNULA, manufactured by Todd Industries, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K810342 · Todd Industries, Inc. · Anesthesiology device
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Mar 1981
Decision
35d
Days
Class 1
Risk

K810342 is an FDA 510(k) clearance for the NASAL CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Todd Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 35 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.

FDA 510(k) Submission Details - K810342

510(k) Number K810342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date March 17, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 25
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K810342.
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · Zimmar Consulting , Ltd. · Nov 1984
CHAD ADJUSTABLE CANNULA
K842968 · Chad Therapeutics, Inc. · Aug 1984
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
K802062 · Hospitak, Inc. · Sep 1980
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · Conphar, Inc. · Jul 1979
NASAL, OXYGEN, CANNULA
K790885 · Airlife, Inc. · May 1979
K810342 · NASAL CANNULA
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