Cleared Traditional

OPUS HC482 DIRECT NASAL MASK (K063036) - FDA 510(k) Clearance

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

K063036 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
80d
Days
Class 2
Risk

K063036 is an FDA 510(k) clearance for the OPUS HC482 DIRECT NASAL MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Manukau, NZ). The FDA issued a Cleared decision on December 22, 2006 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 Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K063036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2006
Decision Date December 22, 2006
Days to Decision 80 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
59d faster than avg
Panel avg: 139d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K063036.
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · Respironics, Inc. · May 2009
COMFORTLITE NASAL MASK
K082558 · Respironics, Inc. · Mar 2009
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996 · Respironics, Inc. · Dec 2007
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006
M-SERIES PRO CPAP SYTEM
K052110 · Respironics, Inc. · Oct 2005