Cleared Traditional

K090804 - NASAL AIRE II PEDIATRIC

K090804 is an FDA 510(k) clearance for NASAL AIRE II PEDIATRIC, manufactured by Innomed Technologies, Inc./Respcare, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K090804 · Innomed Technologies, Inc./Respcare, Inc. · Anesthesiology device
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Nov 2009
Decision
225d
Days
Class 2
Risk

K090804 is an FDA 510(k) clearance for the NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Innomed Technologies, Inc./Respcare, Inc. (Coconut Creek, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 225 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. 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.

View all Innomed Technologies, Inc./Respcare, Inc. devices

FDA 510(k) Submission Details - K090804

510(k) Number K090804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date November 05, 2009
Days to Decision 225 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
85d slower than avg
Panel avg: 140d · This submission: 225d
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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K090804.
F&P ICON SERIES CPAP
K094040 · Fisher &Paykel Healthcare , Ltd. · Apr 2010
EASYCARE ONLINE
K093684 · Resmed, Ltd. · Feb 2010
COMFORTGEL NASAL MASK
K092835 · Respironics Inc., Sleep & Home Respiratory Group · Feb 2010
EASYCARE TX, TX LINK
K092026 · Resmed, Ltd. · Oct 2009
S8 ASPEN WITH H4I PLUS
K091947 · Resmed, Ltd. · Sep 2009
COMFORT TWIN NASAL MASK
K091843 · Respironics Inc., Sleep & Home Respiratory Group · Sep 2009