Cleared Traditional

K830475 - BRAIN MODULE RJ-Z10 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K830475 · Instrumentation Industries, Inc. · Anesthesiology device
Jun 1983
Decision
113d
Days
Class 1
Risk

K830475 is an FDA 510(k) clearance for the BRAIN MODULE RJ-Z10. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K830475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date June 08, 1983
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 225d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.