Cleared Traditional

K791247 - CONPHAR NASAL OXYGEN CANNULA-STERILE

K791247 is an FDA 510(k) clearance for CONPHAR NASAL OXYGEN CANNULA-STERILE, manufactured by Conphar, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K791247 · Conphar, Inc. · Anesthesiology device
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Jul 1979
Decision
18d
Days
Class 1
Risk

K791247 is an FDA 510(k) clearance for the CONPHAR NASAL OXYGEN CANNULA-STERILE. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 18 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 Conphar, Inc. devices

FDA 510(k) Submission Details - K791247

510(k) Number K791247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1979
Decision Date July 24, 1979
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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 14
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K791247.
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
K802062 · Hospitak, Inc. · Sep 1980
NASAL, OXYGEN, CANNULA
K790885 · Airlife, Inc. · May 1979
CANNULAS, DYNACOR'S NASAL OXYGEN
K790056 · Medline Industries, Inc. · Feb 1979
NASAL OXYGEN CANNULA, #017207
K771074 · C.R. Bard, Inc. · Aug 1977