Cleared Special

K040566 - RESMED HOSPITAL NASAL MASK

K040566 is the FDA 510(k) clearance for RESMED HOSPITAL NASAL MASK by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K040566 · Resmed, Ltd. · Anesthesiology device
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Apr 2004
Decision
29d
Days
Class 2
Risk

K040566 is an FDA 510(k) clearance for the RESMED HOSPITAL NASAL MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on April 2, 2004 after a review of 29 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 Resmed, Ltd. devices

Submission Details

510(k) Number K040566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date April 02, 2004
Days to Decision 29 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
111d faster than avg
Panel avg: 140d · This submission: 29d
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 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K040566.
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
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OXYGEN DIVERTER VALVE
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INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · Invacare Corp. · Mar 2004
RESMED S8 PRIME CPAP SYSTEM
K033841 · Resmed, Ltd. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004