Cleared Traditional

K924123 - SIDESTREAM DISPOSABLE

K924123 is an FDA 510(k) clearance for SIDESTREAM DISPOSABLE, 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 91-day FDA review.

K924123 · Medic-Aid , Ltd. · Anesthesiology device
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Nov 1992
Decision
91d
Days
Class 2
Risk

K924123 is an FDA 510(k) clearance for the SIDESTREAM DISPOSABLE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medic-Aid , Ltd. (Sest Sussex Po19 1ts, GB). The FDA issued a Cleared decision on November 16, 1992 after a review of 91 days - within the typical 510(k) review window.

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 - K924123

510(k) Number K924123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date November 16, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
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 K924123.
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
SAM LS
K913095 · Ferguson Medical · Dec 1992
SAM SC
K913096 · Ferguson Medical · Dec 1992
MINI HEART
K923690 · B&B Medical Technologies, Inc. · Oct 1992
HEART NEBULIZER
K923596 · Vortran Medical Technology 1, Inc. · Oct 1992
NE-U07
K922923 · Omron Healthcare, Inc. · Sep 1992