Cleared Traditional

K770633 - BRACKET BE 122-1

K770633 is the FDA 510(k) clearance for BRACKET BE 122-1 by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K770633 · Instrumentation Industries, Inc. · Anesthesiology device
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May 1977
Decision
49d
Days
Class 2
Risk

K770633 is an FDA 510(k) clearance for the BRACKET BE 122-1. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special 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 868.5630 - 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 Instrumentation Industries, Inc. devices

Submission Details

510(k) Number K770633 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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 132
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K770633.
NEBULIZER SET-2C7105
K772222 · Travenol Laboratories, S.A. · Dec 1977
ODUFLEX AEROSOL SET
K771061 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1977
NEBULIZER, MOLEL 503, PART #17068
K771105 · Hospal Medical Corp. · Jul 1977
NEBULIZER HEATER
K770828 · Ohio Medical Products · May 1977
U-MID PREFILLED NEBULIZER
K760585 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976