Cleared Traditional

K982043 - BRENEB

K982043 is an FDA 510(k) clearance for BRENEB, manufactured by Bremed Italia, S.R.L.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K982043 · Bremed Italia, S.R.L. · Anesthesiology device
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Nov 1998
Decision
152d
Days
Class 2
Risk

K982043 is an FDA 510(k) clearance for the BRENEB. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Bremed Italia, S.R.L. (Arnold, US). The FDA issued a Cleared decision on November 9, 1998 after a review of 152 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 Bremed Italia, S.R.L. devices

FDA 510(k) Submission Details - K982043

510(k) Number K982043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1998
Decision Date November 09, 1998
Days to Decision 152 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
12d slower than avg
Panel avg: 140d · This submission: 152d
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 248
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K982043.
LS SERIES 200 FLOVISION SYSTEM
K971981 · Systam · Dec 1998
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · Salter Labs · Dec 1998
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K981249 · Instrumentation Industries, Inc. · Nov 1998
MYSTIQUE ULTRASONIC NEBULIZER
K983002 · Airsep Corp. · Oct 1998
BREATHERITE
K981944 · Ventlab Corp. · Aug 1998
HOPE NEBULIZER
K980407 · B&B Medical Technologies, Inc. · May 1998