Cleared Traditional

K050171 - IT NASAL MASK

K050171 is an FDA 510(k) clearance for IT NASAL MASK, manufactured by Innomed Technologies. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K050171 · Innomed Technologies · Anesthesiology device
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May 2005
Decision
98d
Days
Class 2
Risk

K050171 is an FDA 510(k) clearance for the IT NASAL MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Innomed Technologies (Coconut Creek, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 98 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.

View all Innomed Technologies devices

FDA 510(k) Submission Details - K050171

510(k) Number K050171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date May 04, 2005
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
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 351
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K050171.
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · Fisher &Paykel Healthcare , Ltd. · May 2005
PIONEER U121 SERIES CPAP
K041823 · Merits Health Products Co., Ltd. · May 2005
RESSCAN
K050775 · Resmed, Ltd. · May 2005
ULTRA MIRAGE II MASK
K050359 · Resmed, Ltd. · Mar 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · Salter Labs · Mar 2005
RESMED MERIDIAN MASK
K050142 · Resmed, Ltd. · Mar 2005