Cleared Traditional

K903504 - HALA'TUS 1 OXYGENATOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903504 · The Henry G. Dietz Co., Inc. · Anesthesiology device
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Jan 1991
Decision
178d
Days
Class 2
Risk

K903504 is an FDA 510(k) clearance for the HALA'TUS 1 OXYGENATOR. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by The Henry G. Dietz Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 The Henry G. Dietz Co., Inc. devices

Submission Details

510(k) Number K903504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date January 28, 1991
Days to Decision 178 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 139d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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.