Cleared Traditional

K903504 - HALA'TUS 1 OXYGENATOR

K903504 is an FDA 510(k) clearance for HALA'TUS 1 OXYGENATOR, manufactured by The Henry G. Dietz Co., Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 178-day FDA review.

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

FDA 510(k) Submission Details - K903504

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
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NFB Conserver, Oxygen

All 55
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K903504.
AIRSEP IMPULSE
K962766 · Airsep Corp. · Oct 1996
OXYPULSE EOC I, EOC II & EOC R
K955129 · Eagle Medical Equipment Co. · Feb 1996
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · Salter Labs · Feb 1989