Cleared Special

O2N DEMAND-II, VICTOR MODEL OCPR-II (K992659) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992659 · Thermadyne Holings Corp. · Anesthesiology device
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Sep 1999
Decision
25d
Days
Class 2
Risk

K992659 is an FDA 510(k) clearance for the O2N DEMAND-II, VICTOR MODEL OCPR-II. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Thermadyne Holings Corp. (Denton, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Thermadyne Holings Corp. devices

Submission Details

510(k) Number K992659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date September 03, 1999
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - NFB Conserver, Oxygen

All 9
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