Cleared Traditional

K770631 - FLEX ARM BE 122, CLAMP 122-27 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K770631 · Instrumentation Industries, Inc. · Anesthesiology device
May 1977
Decision
49d
Days
Class 1
Risk

K770631 is an FDA 510(k) clearance for the FLEX ARM BE 122, CLAMP 122-27. Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1977 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5280 - 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 K770631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1977
Decision Date May 23, 1977
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
176d faster than avg
Panel avg: 225d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAY Support, Breathing Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5280
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.