Cleared Traditional

K990659 - NASAL AIRE

K990659 is an FDA 510(k) clearance for NASAL AIRE, manufactured by Breathing Technologies Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K990659 · Breathing Technologies Corp. · Anesthesiology device
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Nov 1999
Decision
270d
Days
Class 2
Risk

K990659 is an FDA 510(k) clearance for the NASAL AIRE. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Breathing Technologies Corp. (Cary, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 270 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 Breathing Technologies Corp. devices

FDA 510(k) Submission Details - K990659

510(k) Number K990659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date November 26, 1999
Days to Decision 270 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
130d slower than avg
Panel avg: 140d · This submission: 270d
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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K990659.
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RESPIRONICS TOTAL FACE MASK
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IQ NASAL MASK, MODEL P/N 50160
K993269 · Sleepnet Corporation · Oct 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999