Cleared Traditional

K840897 - OXYGEN TUBING

K840897 is an FDA 510(k) clearance for OXYGEN TUBING, manufactured by Medical Technologies of Georgia. 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.

K840897 · Medical Technologies of Georgia · Anesthesiology device
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Mar 1984
Decision
18d
Days
Class 1
Risk

K840897 is an FDA 510(k) clearance for the OXYGEN TUBING. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Medical Technologies of Georgia (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 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 Medical Technologies of Georgia devices

FDA 510(k) Submission Details - K840897

510(k) Number K840897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date March 16, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
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 20
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K840897.
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · Zimmar Consulting , Ltd. · Nov 1984
CHAD ADJUSTABLE CANNULA
K842968 · Chad Therapeutics, Inc. · Aug 1984
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
K802062 · Hospitak, Inc. · Sep 1980
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · Conphar, Inc. · Jul 1979