Cleared Traditional

K833922 - BRETHANCER, DRUG DELIVERY SYS-INHAL

K833922 is an FDA 510(k) clearance for BRETHANCER, manufactured by Ciba-Geigy Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K833922 · Ciba-Geigy Corp. · Anesthesiology device
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Dec 1983
Decision
24d
Days
Class 2
Risk

K833922 is an FDA 510(k) clearance for the BRETHANCER, DRUG DELIVERY SYS-INHAL. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ciba-Geigy Corp. (Walker, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 24 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.

FDA 510(k) Submission Details - K833922

510(k) Number K833922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date December 08, 1983
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K833922.
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
LUNG AEROSOL UNIT
K800023 · Cadema Medical Products, Inc. · Jan 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983
USE 77 ULTRASONIC NEBULIZER
K832086 · Medlog GmbH Marketing Services · Jul 1983
DISPOS. MEDICATION NEBULIZER
K831270 · Hospitak, Inc. · Jun 1983
K833922 · BRETHANCER, DRUG DELIVERY SYS-INHAL
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