Cleared Traditional

K770487 - LIGHTWEIGHT PLASTIC CANNULA

K770487 is an FDA 510(k) clearance for LIGHTWEIGHT PLASTIC CANNULA, manufactured by Hudson Oxygen Therapy Sales Co.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770487 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Mar 1977
Decision
7d
Days
Class 1
Risk

K770487 is an FDA 510(k) clearance for the LIGHTWEIGHT PLASTIC CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1977 after a review of 7 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 Hudson Oxygen Therapy Sales Co. devices

FDA 510(k) Submission Details - K770487

510(k) Number K770487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1977
Decision Date March 21, 1977
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
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 19
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K770487.
CANNULAS, DYNACOR'S NASAL OXYGEN
K790056 · Medline Industries, Inc. · Feb 1979
NASAL OXYGEN CANNULA, #017207
K771074 · C.R. Bard, Inc. · Aug 1977
OXYGEN CANNULA
K770996 · Ohio Medical Products · Jun 1977
CANNULA, ARGYLE NASAL OXYGEN
K760337 · Sherwood Medical Industries · Aug 1976
CANNULA, NASAL, FOR OXYGEN
K760080 · Inspiron Corp. · Jul 1976