Cleared Traditional

K936047 - SPECTRUM(TM) MASK

K936047 is an FDA 510(k) clearance for SPECTRUM(TM) MASK, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 464-day FDA review.

K936047 · Respironics, Inc. · Anesthesiology device
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Mar 1995
Decision
464d
Days
Class 2
Risk

K936047 is an FDA 510(k) clearance for the SPECTRUM(TM) 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 March 29, 1995 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K936047

510(k) Number K936047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date March 29, 1995
Days to Decision 464 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
324d slower than avg
Panel avg: 140d · This submission: 464d
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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K936047.
ARIA CPAP SYSTEM
K953341 · Respironics, Inc. · Jan 1996
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292 · Puritan Bennett Corp. · Nov 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
K950331 · Healthdyne, Inc. · Sep 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
K935979 · Devilbiss Health Care, Inc. · Nov 1994
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993