Cleared Traditional

K771074 - NASAL OXYGEN CANNULA

K771074 is an FDA 510(k) clearance for NASAL OXYGEN CANNULA, manufactured by C.R. Bard, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K771074 · C.R. Bard, Inc. · Anesthesiology device
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Aug 1977
Decision
51d
Days
Class 1
Risk

K771074 is an FDA 510(k) clearance for the NASAL OXYGEN CANNULA, #017207. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 51 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K771074

510(k) Number K771074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1977
Decision Date August 04, 1977
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
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 16
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K771074.
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
OXYGEN CANNULA
K770996 · Ohio Medical Products · Jun 1977
LIGHTWEIGHT PLASTIC CANNULA
K770487 · Hudson Oxygen Therapy Sales Co. · Mar 1977
CANNULA, ARGYLE NASAL OXYGEN
K760337 · Sherwood Medical Industries · Aug 1976