Cleared Traditional

K844083 - STRAIGHT AND BUBBLE OXYGEN TUBING

K844083 is the FDA 510(k) clearance for STRAIGHT AND BUBBLE OXYGEN TUBING by Hudson Extrusions, Inc.. It is a Class 1 Anesthesiology device (product code CAT) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K844083 · Hudson Extrusions, Inc. · Anesthesiology device
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Oct 1984
Decision
11d
Days
Class 1
Risk

K844083 is an FDA 510(k) clearance for the STRAIGHT AND BUBBLE OXYGEN TUBING. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Hudson Extrusions, Inc. (Hudson, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 11 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 Extrusions, Inc. devices

Submission Details

510(k) Number K844083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date October 30, 1984
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
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 K844083.
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