Cleared Traditional

K823506 - NASAL CANNULA

K823506 is an FDA 510(k) clearance for NASAL CANNULA, manufactured by Seven Harvest Intl. Import & Export. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K823506 · Seven Harvest Intl. Import & Export · Anesthesiology device
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Dec 1982
Decision
15d
Days
Class 1
Risk

K823506 is an FDA 510(k) clearance for the NASAL CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Seven Harvest Intl. Import & Export (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 15 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 Seven Harvest Intl. Import & Export devices

FDA 510(k) Submission Details - K823506

510(k) Number K823506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1982
Decision Date December 09, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
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 22
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K823506.
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