Cleared Special

IQ NASAL MASK, MODEL P/N 50160 (K993269) - FDA 510(k) Clearance

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

K993269 · Sleepnet Corporation · Anesthesiology device
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Oct 1999
Decision
27d
Days
Class 2
Risk

K993269 is an FDA 510(k) clearance for the IQ NASAL MASK, MODEL P/N 50160. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 27 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sleepnet Corporation devices

Submission Details

510(k) Number K993269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date October 27, 1999
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 140d · This submission: 27d
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 K993269.
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · Puritan Bennett Corp. · Sep 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000
RESPIRONICS TOTAL FACE MASK
K992969 · Respironics, Inc. · Nov 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · Respironics, Inc. · Oct 1999
MONARCH II MINI MASK
K992336 · Respironics, Inc. · Aug 1999