Cleared Special

K033087 - ORACLE ORAL MASK

K033087 is the FDA 510(k) clearance for ORACLE ORAL MASK by Fisher &Paykel Healthcare , Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Special 510(k) pathway after a 107-day FDA review.

K033087 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Jan 2004
Decision
107d
Days
Class 2
Risk

K033087 is an FDA 510(k) clearance for the ORACLE ORAL MASK, MODEL HC451A. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, Auckland, NZ). The FDA issued a Cleared decision on January 14, 2004 after a review of 107 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K033087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date January 14, 2004
Days to Decision 107 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
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 - BZD Ventilator, Non-continuous (respirator)

All 266
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K033087.
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
APEX MEDICAL CPAP RT 21XX
K022650 · Apex Medical Corp. · Feb 2004
MIRAGE ACTIVA MASK
K032916 · Resmed, Ltd. · Dec 2003
NASAL JACKS MASK
K032433 · Resmed, Ltd. · Oct 2003
AUTOSET SPIRIT SYSTEM
K032480 · Resmed, Ltd. · Oct 2003