Cleared Traditional

K963247 - VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR

K963247 is an FDA 510(k) clearance for VICTOR MODEL OCPR OXYGEN CONSERVING PRE..., manufactured by Thermadyne Holings Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K963247 · Thermadyne Holings Corp. · Anesthesiology device
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Nov 1996
Decision
80d
Days
Class 2
Risk

K963247 is an FDA 510(k) clearance for the VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR. 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 November 7, 1996 after a review of 80 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 Thermadyne Holings Corp. devices

FDA 510(k) Submission Details - K963247

510(k) Number K963247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date November 07, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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 53
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K963247.
PULSED OXYGEN CONSERVING DEVICE, POCD
K983459 · Medical Electronic Devices, Inc. · Dec 1998
SANPO I
K964541 · Koike Medical Co. · Sep 1997
FLOTEC OXYSAVRR (S)
K970371 · Flotec, Inc. · Jul 1997
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
K962944 · Transtracheal Systems · Oct 1996
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996
AIRSEP IMPULSE
K962766 · Airsep Corp. · Oct 1996