Cleared Traditional

K981944 - BREATHERITE

K981944 is an FDA 510(k) clearance for BREATHERITE, manufactured by Ventlab Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K981944 · Ventlab Corp. · Anesthesiology device

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Aug 1998

Decision

82d

Days

Class 2

Risk

K981944 is an FDA 510(k) clearance for the BREATHERITE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ventlab Corp. (Crofton, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 82 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 Ventlab Corp. devices

FDA 510(k) Submission Details - K981944

510(k) Number	K981944 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 1998
Decision Date	August 24, 1998
Days to Decision	82 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

58d faster than avg

Panel avg: 140d · This submission: 82d

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 198

Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K981944.

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

K982722 · Ambu, Inc. · Apr 1999

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

HOPE NEBULIZER

K980407 · B&B Medical Technologies, Inc. · May 1998

MODEL IRC 1199 SCOUT NEBULIZER

K973468 · Invacare Corp. · Dec 1997

COMPRESSOR/NEBULIZER #3650

K970289 · Devilbiss Health Care, Inc. · Apr 1997

FDA 510(k) Resources - Anesthesiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K981944

Ventlab Corp.

Crofton, MD · US

E.J. Smith

Regulatory profile

22 submissions 22 cleared

100% clearance rate · Active in Anesthesiology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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