Cleared Traditional

K770634 - ADAPTER BE 105-101 & 125-101 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K770634 · Instrumentation Industries, Inc. · Anesthesiology device
Apr 1977
Decision
4d
Days
Class 1
Risk

K770634 is an FDA 510(k) clearance for the ADAPTER BE 105-101 & 125-101. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1977 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 K770634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1977
Decision Date April 08, 1977
Days to Decision 4 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
221d faster than avg
Panel avg: 225d · This submission: 4d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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.