Cleared Traditional

K894215 - EVOLUTION ULTRASONIC

K894215 is an FDA 510(k) clearance for EVOLUTION ULTRASONIC, manufactured by Medical Industries America, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K894215 · Medical Industries America, Inc. · Anesthesiology device
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Apr 1990
Decision
301d
Days
Class 1
Risk

K894215 is an FDA 510(k) clearance for the EVOLUTION ULTRASONIC. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Medical Industries America, Inc. (West Des Moines, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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. Elevated predicate reliance profile. 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 Medical Industries America, Inc. devices

FDA 510(k) Submission Details - K894215

510(k) Number K894215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date April 16, 1990
Days to Decision 301 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 140d · This submission: 301d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 21
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K894215.
SALINE SOLUTION- STERILE
K922033 · Trinity Laboratories, Inc. · Jul 1992
MODIFIED AEROCHAMBER WITH MASK
K900576 · Monaghan Medical Corp. · May 1991
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER
K900557 · Monaghan Medical Corp. · Apr 1991
PFEIFFER METERED DOSAGE SYSTEM
K896070 · Syva Co. · Jan 1990
FREEWAY NEBULIZER COMPRESSOR
K895592 · Lifecare Services, Inc. · Nov 1989
DEVILBISS MODEL 6610D
K894441 · Devilbiss Health Care, Inc. · Oct 1989