Cleared Traditional

K923698 - BETAMIST 2

K923698 is an FDA 510(k) clearance for BETAMIST 2, manufactured by Rantran, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K923698 · Rantran, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
209d
Days
Class 2
Risk

K923698 is an FDA 510(k) clearance for the BETAMIST 2. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Rantran, Inc. (Ashland, US). The FDA issued a Cleared decision on February 18, 1993 after a review of 209 days - an extended review 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: 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.

View all Rantran, Inc. devices

FDA 510(k) Submission Details - K923698

510(k) Number K923698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date February 18, 1993
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 140d · This submission: 209d
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 376
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K923698.
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
K924667 · Vortran Medical Technology 1, Inc. · Aug 1993
SOFT-MIST(TM)
K924649 · Vortran Medical Technology 1, Inc. · May 1993
DEVILBISS MODEL 5650 PULMO-AIDE
K923888 · Devilbiss Health Care, Inc. · Feb 1993
PRECISION MIST COMPRESSOR
K923324 · Precision Medical, Inc. · Jan 1993
MICROFLOW
K924684 · Mountain Medical Equipment, Inc. · Dec 1992
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992