Cleared Traditional

K894441 - DEVILBISS MODEL 6610D

K894441 is an FDA 510(k) clearance for DEVILBISS MODEL 6610D, manufactured by Devilbiss Health Care, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K894441 · Devilbiss Health Care, Inc. · Anesthesiology device
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Oct 1989
Decision
88d
Days
Class 1
Risk

K894441 is an FDA 510(k) clearance for the DEVILBISS MODEL 6610D. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 88 days - a notably fast clearance cycle.

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: 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 Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K894441

510(k) Number K894441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date October 13, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
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 22
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K894441.
EVOLUTION ULTRASONIC
K894215 · Medical Industries America, Inc. · Apr 1990
PFEIFFER METERED DOSAGE SYSTEM
K896070 · Syva Co. · Jan 1990
FREEWAY NEBULIZER COMPRESSOR
K895592 · Lifecare Services, Inc. · Nov 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · Devilbiss Health Care, Inc. · Oct 1989
MONAGHAN AEROCHAMBER WITH MASK
K874513 · Monaghan Medical Corp. · Dec 1987
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
K873477 · Vortran Medical Technology 1, Inc. · Oct 1987