Cleared Traditional

K934749 - FREEWAY LITE NEBULIZER COMPRESSOR

K934749 is an FDA 510(k) clearance for FREEWAY LITE NEBULIZER COMPRESSOR, manufactured by Medic-Aid , Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K934749 · Medic-Aid , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
294d
Days
Class 2
Risk

K934749 is an FDA 510(k) clearance for the FREEWAY LITE NEBULIZER COMPRESSOR. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medic-Aid , Ltd. (Sussex, U.K. Po21 3pp, GB). The FDA issued a Cleared decision on July 25, 1994 after a review of 294 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Medic-Aid , Ltd. devices

FDA 510(k) Submission Details - K934749

510(k) Number K934749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date July 25, 1994
Days to Decision 294 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 140d · This submission: 294d
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 248
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K934749.
UNIHEART
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AEROCHAMBER W/MASK, MODIFIED
K930574 · Monaghan Medical Corp. · Jan 1994
VENTI-GENTLE-HALER(TM)
K933915 · Vortran Medical Technology 1, Inc. · Oct 1993
STERI-CATH MDI
K923559 · Concord/Portex · Oct 1993