Cleared Traditional

K823481 - BE #16 - MANIFOLD (FDA 510(k) Clearance)

Class I Anesthesiology device.

K823481 · Instrumentation Industries, Inc. · Anesthesiology device
Dec 1982
Decision
29d
Days
Class 1
Risk

K823481 is an FDA 510(k) clearance for the BE #16 - MANIFOLD. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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.

Submission Details

510(k) Number K823481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date December 22, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
196d faster than avg
Panel avg: 225d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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.