Cleared Traditional

K042455 - DEVILBISS NASAL CPAP MASK, 9354 SERIES

K042455 is an FDA 510(k) clearance for DEVILBISS NASAL CPAP MASK, manufactured by Sunrise Medical. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K042455 · Sunrise Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
126d
Days
Class 2
Risk

K042455 is an FDA 510(k) clearance for the DEVILBISS NASAL CPAP MASK, 9354 SERIES. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on January 14, 2005 after a review of 126 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042455

510(k) Number K042455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2004
Decision Date January 14, 2005
Days to Decision 126 days
Submission Type Traditional
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
14d faster than avg
Panel avg: 140d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 458
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K042455.
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
K043282 · Sunrise Medical · Feb 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
K043382 · Tiara Medical Systems, Inc. · Jan 2005
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
K042294 · Suiter Enterprises, Inc. · Sep 2004
AURA CPAP PATIENT INTERFACE
K042130 · Aeiomed, Inc. · Sep 2004