Cleared Special

PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 (K093124) - FDA 510(k) Clearance

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

K093124 · Cardinal Health 207, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
159d
Days
Class 2
Risk

K093124 is an FDA 510(k) clearance for the PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE.... Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Cardinal Health 207, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 159 days - an extended review 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. 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 Cardinal Health 207, Inc. devices

Submission Details

510(k) Number K093124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date March 10, 2010
Days to Decision 159 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 140d · This submission: 159d
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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K093124.
GOLIFE NASAL MASK
K102502 · Respironics, Inc. · Dec 2010
PIXI PEDIATRIC MASK
K102224 · Resmed, Ltd. · Dec 2010
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
K100772 · Resmed, Ltd. · Jun 2010
EASYCARE ONLINE
K093684 · Resmed, Ltd. · Feb 2010
EASYCARE TX, TX LINK
K092026 · Resmed, Ltd. · Oct 2009
S8 ASPEN WITH H4I PLUS
K091947 · Resmed, Ltd. · Sep 2009