Cleared Traditional

K904398 - WATER COLUMN RELIEF VALVE

K904398 is an FDA 510(k) clearance for WATER COLUMN RELIEF VALVE, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K904398 · Icn Pharmaceuticals, Inc. · Anesthesiology device
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Jul 1991
Decision
287d
Days
Class 2
Risk

K904398 is an FDA 510(k) clearance for the WATER COLUMN RELIEF VALVE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 287 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 Icn Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K904398

510(k) Number K904398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date July 09, 1991
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
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 245
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K904398.
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
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DEVILBISS MODEL 5000
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MINI-MICRON CIRCUIT
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TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990