Cleared Special

K992969 - RESPIRONICS TOTAL FACE MASK

K992969 is an FDA 510(k) clearance for RESPIRONICS TOTAL FACE MASK, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 68-day FDA review.

K992969 · Respironics, Inc. · Anesthesiology device
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Nov 1999
Decision
68d
Days
Class 2
Risk

K992969 is an FDA 510(k) clearance for the RESPIRONICS TOTAL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 68 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K992969

510(k) Number K992969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date November 10, 1999
Days to Decision 68 days
Submission Type Special
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
72d faster than avg
Panel avg: 140d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K992969.
BREAS PV 100 CPAP SYSTEM
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BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856 · Bird Products Corp. · Jan 2000
IQ NASAL MASK, MODEL P/N 50160
K993269 · Sleepnet Corporation · Oct 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · Respironics, Inc. · Oct 1999