Cleared Traditional

K830988 - OXYGEN CONNECTING TUBE

K830988 is the FDA 510(k) clearance for OXYGEN CONNECTING TUBE by Medovations, Inc.. It is a Class 1 Anesthesiology device (product code BYX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K830988 · Medovations, Inc. · Anesthesiology device
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May 1983
Decision
35d
Days
Class 1
Risk

K830988 is an FDA 510(k) clearance for the OXYGEN CONNECTING TUBE. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Medovations, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1983 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 Medovations, Inc. devices

Submission Details

510(k) Number K830988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date May 03, 1983
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 10
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K830988.
FLEXTUBE, CONNECTING TUBING
K860877 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K853569 · Medipart Jerry Alexander · Nov 1985
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