Cleared Traditional

K873477 - INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)

K873477 is an FDA 510(k) clearance for INTERMITTENT SIGNAL ACTUATED NEBULIZER ..., manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K873477 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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Oct 1987
Decision
39d
Days
Class 1
Risk

K873477 is an FDA 510(k) clearance for the INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN). Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 39 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 Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K873477

510(k) Number K873477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date October 09, 1987
Days to Decision 39 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
101d faster than avg
Panel avg: 140d · This submission: 39d
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 K873477.
DEVILBISS MODEL 6610D
K894441 · Devilbiss Health Care, Inc. · Oct 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · Devilbiss Health Care, Inc. · Oct 1989
MONAGHAN AEROCHAMBER WITH MASK
K874513 · Monaghan Medical Corp. · Dec 1987
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · Automatic Liquid Packaging, Inc. · Apr 1987
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
K870027 · Salter Labs · Mar 1987
CHALLENGER DOSIMETER
K870755 · Salter Labs · Mar 1987