Cleared Traditional

K760337 - CANNULA, ARGYLE NASAL OXYGEN

K760337 is an FDA 510(k) clearance for CANNULA, manufactured by Sherwood Medical Industries. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K760337 · Sherwood Medical Industries · Anesthesiology device
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Aug 1976
Decision
12d
Days
Class 1
Risk

K760337 is an FDA 510(k) clearance for the CANNULA, ARGYLE NASAL OXYGEN. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on August 11, 1976 after a review of 12 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 - K760337

510(k) Number K760337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1976
Decision Date August 11, 1976
Days to Decision 12 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
128d faster than avg
Panel avg: 140d · This submission: 12d
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 41
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K760337.
OXYGEN CANNULA
K770996 · Ohio Medical Products · Jun 1977
LIGHTWEIGHT PLASTIC CANNULA
K770487 · Hudson Oxygen Therapy Sales Co. · Mar 1977
CANNULA, LARRIAT
K760551 · Landmark Plastics · Sep 1976
CANNULA, DISPOSABLE OXYGEN TTHERAPY
K760330 · Inhal-O-Tech Medical Plastic · Aug 1976
CANNULAE, PLASTIC DISPOSABLE NASAL
K760218 · Manner Medical Products · Aug 1976
CANNULA, NASAL, FOR OXYGEN
K760080 · Inspiron Corp. · Jul 1976
K760337 · CANNULA, ARGYLE NASAL OXYGEN
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