Cleared Traditional

K872826 - ULTRA-NEB 99 ULTRASONIC NEBULIZER

K872826 is an FDA 510(k) clearance for ULTRA-NEB 99 ULTRASONIC NEBULIZER, manufactured by The Devilbiss Co.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K872826 · The Devilbiss Co. · Anesthesiology device
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Sep 1987
Decision
50d
Days
Class 2
Risk

K872826 is an FDA 510(k) clearance for the ULTRA-NEB 99 ULTRASONIC NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by The Devilbiss Co. (Somerset, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 50 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 The Devilbiss Co. devices

FDA 510(k) Submission Details - K872826

510(k) Number K872826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date September 04, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 140d · This submission: 50d
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 403
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K872826.
ASTHMAKIT
K874047 · Dhd Medical Products Div. Diemolding Corp. · Feb 1988
RESPIRGARD II NEBULIZER SYSTEM
K874395 · Marquest Medical Products, Inc. · Dec 1987
HOYER SOLVET
K873395 · Infrasonics Corp. · Oct 1987
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985