Cleared Traditional

K935533 - NASAL CANNULA

K935533 is the FDA 510(k) clearance for NASAL CANNULA by Puritas Health Care, Inc.. It is a Class 1 Anesthesiology device (product code CAT) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K935533 · Puritas Health Care, Inc. · Anesthesiology device
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Feb 1994
Decision
79d
Days
Class 1
Risk

K935533 is an FDA 510(k) clearance for the NASAL CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 79 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 Puritas Health Care, Inc. devices

Submission Details

510(k) Number K935533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date February 03, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K935533.
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
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
NASAL OXYGEN CANNULA, #017207
K771074 · C.R. Bard, Inc. · Aug 1977