Cleared Traditional

QUARTET CLINICAL SYSTEM (K963761) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963761 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
212d
Days
Class 2
Risk

K963761 is an FDA 510(k) clearance for the QUARTET CLINICAL SYSTEM. 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 April 18, 1997 after a review of 212 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 Respironics, Inc. devices

Submission Details

510(k) Number K963761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date April 18, 1997
Days to Decision 212 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
72d slower than avg
Panel avg: 140d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 118
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K963761.
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · Respironics, Inc. · Oct 1999
MONARCH II MINI MASK
K992336 · Respironics, Inc. · Aug 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
BIPAP DUET SYSTEM
K964363 · Respironics, Inc. · Jan 1997
WHISPER SWIVEL II EXHALATION PORT
K962203 · Respironics, Inc. · Dec 1996
PRESSURE VALVE
K963250 · Respironics, Inc. · Nov 1996