Cleared Traditional

K823142 - OXYGEN TUBINGS

K823142 is the FDA 510(k) clearance for OXYGEN TUBINGS by Seven Harvest Intl. Import & Export. It is a Class 1 Anesthesiology device (product code BYX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823142 · Seven Harvest Intl. Import & Export · Anesthesiology device
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Nov 1982
Decision
35d
Days
Class 1
Risk

K823142 is an FDA 510(k) clearance for the OXYGEN TUBINGS. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Seven Harvest Intl. Import & Export (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 Seven Harvest Intl. Import & Export devices

Submission Details

510(k) Number K823142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
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 - BYX Tubing, Pressure And Accessories

All 8
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K823142.
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K801190 · Airlife, Inc. · May 1980
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K791821 · Airlife, Inc. · Sep 1979
TUBING CORRUGATED
K790147 · Airlife, Inc. · Feb 1979
TUBING, E.V.A. FLEXIBLE
K790158 · Airlife, Inc. · Feb 1979
CORRUGATED FLEXIBLE E.V.A. TUBING
K790159 · Airlife, Inc. · Feb 1979
OXYGEN TUBING, W/VINYL AND LATEX TIPS
K790160 · Airlife, Inc. · Feb 1979