Cleared Traditional

K895592 - FREEWAY NEBULIZER COMPRESSOR

K895592 is an FDA 510(k) clearance for FREEWAY NEBULIZER COMPRESSOR, manufactured by Lifecare Services, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K895592 · Lifecare Services, Inc. · Anesthesiology device
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Nov 1989
Decision
67d
Days
Class 1
Risk

K895592 is an FDA 510(k) clearance for the FREEWAY NEBULIZER COMPRESSOR. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Lifecare Services, Inc. (Lafayette, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 67 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 Lifecare Services, Inc. devices

FDA 510(k) Submission Details - K895592

510(k) Number K895592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date November 21, 1989
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 24
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K895592.
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