Cleared Traditional

K833127 - ARGYLE NASAL CANNULA

K833127 is an FDA 510(k) clearance for ARGYLE NASAL CANNULA, manufactured by Sherwood Medical Co.. 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.

K833127 · Sherwood Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
51d
Days
Class 1
Risk

K833127 is an FDA 510(k) clearance for the ARGYLE NASAL CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983 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.

FDA 510(k) Submission Details - K833127

510(k) Number K833127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1983
Decision Date November 03, 1983
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 41
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K833127.
POLYVINYL CHLORIDE CANNULAS
K844084 · Hudson Extrusions, Inc. · Oct 1984
CHAD ADJUSTABLE CANNULA
K842968 · Chad Therapeutics, Inc. · Aug 1984
OXYGEN TUBING
K840897 · Medical Technologies of Georgia · Mar 1984
NASAL CANNULA
K823506 · Seven Harvest Intl. Import & Export · Dec 1982
OECO NASAL CANNULA
K811789 · Oeco · Jul 1981
NASAL CANNULA
K810342 · Todd Industries, Inc. · Mar 1981
K833127 · ARGYLE NASAL CANNULA
Download PDF Sherwood Medical Co.