Cleared Traditional

K971933 - PORT-NEB

K971933 is an FDA 510(k) clearance for PORT-NEB, 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 66-day FDA review.

K971933 · Medic-Aid , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
66d
Days
Class 2
Risk

K971933 is an FDA 510(k) clearance for the PORT-NEB. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medic-Aid , Ltd. (Mccordsville, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 66 days - a notably fast clearance 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: 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 Medic-Aid , Ltd. devices

FDA 510(k) Submission Details - K971933

510(k) Number K971933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date August 01, 1997
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
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 247
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K971933.
STERILE WATER FOR INHALATION, USP
K972467 · Holopack International, LP · Aug 1997
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K972371 · Brasamerica Medical Equipment, Inc. · Aug 1997
MDILOG, MODEL MDC-511
K970344 · Medtrak Technologies, Inc. · Aug 1997
HAND HELD MEDISPACER
K972237 · Thayer Medical Corp. · Jul 1997
MASTER NEB II
K970542 · Bremed Italia, S.R.L. · Jun 1997
COMPRESSOR/NEBULIZER #3650
K970289 · Devilbiss Health Care, Inc. · Apr 1997