Cleared Traditional

K831082 - CONNECTING TUBING (FDA 510(k) Clearance)

Class I Anesthesiology device.

K831082 · The Kendall Company Div. of Tyco Healthcare Group · Anesthesiology device
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May 1983
Decision
35d
Days
Class 1
Risk

K831082 is an FDA 510(k) clearance for the CONNECTING TUBING. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by The Kendall Company Div. of Tyco Healthcare Group (Mchenry, US). The FDA issued a Cleared decision on May 9, 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 The Kendall Company Div. of Tyco Healthcare Group devices

Submission Details

510(k) Number K831082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date May 09, 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
104d faster than avg
Panel avg: 139d · 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.