Cleared Traditional

K930574 - AEROCHAMBER W/MASK

K930574 is an FDA 510(k) clearance for AEROCHAMBER W/MASK, manufactured by Monaghan Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K930574 · Monaghan Medical Corp. · Anesthesiology device
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Jan 1994
Decision
354d
Days
Class 2
Risk

K930574 is an FDA 510(k) clearance for the AEROCHAMBER W/MASK, MODIFIED. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on January 24, 1994 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K930574

510(k) Number K930574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date January 24, 1994
Days to Decision 354 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
214d slower than avg
Panel avg: 140d · This submission: 354d
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 191
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K930574.
UNIHEART
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K944643 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K935693 · Vortran Medical Technology 1, Inc. · Aug 1994
VENTI-GENTLE-HALER(TM)
K933915 · Vortran Medical Technology 1, Inc. · Oct 1993
STERI-CATH MDI
K923559 · Concord/Portex · Oct 1993
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
K924667 · Vortran Medical Technology 1, Inc. · Aug 1993