Cleared Special

K002465 - SPECTRUM 2 REUSABLE FULL FACE MASK

K002465 is an FDA 510(k) clearance for SPECTRUM 2 REUSABLE FULL 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 28-day FDA review.

K002465 · Respironics, Inc. · Anesthesiology device
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Sep 2000
Decision
28d
Days
Class 2
Risk

K002465 is an FDA 510(k) clearance for the SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876. 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 September 8, 2000 after a review of 28 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 - K002465

510(k) Number K002465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date September 08, 2000
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 K002465.
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · Puritan Bennett Corp. · Sep 2000
BREAS PV 100 CPAP SYSTEM
K001553 · Vital Signs, Inc. · Aug 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000