Cleared Traditional

K051988 - OXY-SERVE II OXYGEN CONSERVING REGULATOR (FDA 510(k) Clearance)

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

K051988 · Superior Products, Inc. · Anesthesiology device
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Sep 2005
Decision
61d
Days
Class 2
Risk

K051988 is an FDA 510(k) clearance for the OXY-SERVE II OXYGEN CONSERVING REGULATOR. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Superior Products, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 21, 2005 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Superior Products, Inc. devices

Submission Details

510(k) Number K051988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2005
Decision Date September 21, 2005
Days to Decision 61 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 139d · This submission: 61d
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.