Cleared Abbreviated

AURA CPAP SYSTEM (K042945) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K042945 · Aeiomed, Inc. · Anesthesiology device
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Mar 2005
Decision
135d
Days
Class 2
Risk

K042945 is an FDA 510(k) clearance for the AURA CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Aeiomed, Inc. (Stoughton, US). The FDA issued a Cleared decision on March 9, 2005 after a review of 135 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aeiomed, Inc. devices

Submission Details

510(k) Number K042945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2004
Decision Date March 09, 2005
Days to Decision 135 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 140d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K042945.
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005
RESSCAN
K050775 · Resmed, Ltd. · May 2005
ULTRA MIRAGE II MASK
K050359 · Resmed, Ltd. · Mar 2005
RESMED MERIDIAN MASK
K050142 · Resmed, Ltd. · Mar 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004