Cleared Traditional

K964363 - BIPAP DUET SYSTEM

K964363 is an FDA 510(k) clearance for BIPAP DUET SYSTEM, 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 90-day FDA review.

K964363 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
90d
Days
Class 2
Risk

K964363 is an FDA 510(k) clearance for the BIPAP DUET 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 January 30, 1997 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K964363

510(k) Number K964363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date January 30, 1997
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K964363.
MORPHEE PLUS ALPHA
K964019 · Nellcor Puritan Bennett, Inc. · Jun 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · Resmed, Ltd. · May 1997
QUARTET CLINICAL SYSTEM
K963761 · Respironics, Inc. · Apr 1997
WHISPER SWIVEL II EXHALATION PORT
K962203 · Respironics, Inc. · Dec 1996
PRESSURE VALVE
K963250 · Respironics, Inc. · Nov 1996
DPAP STEALTH SLEEPNET MODEL NUMBER 84000
K962713 · Sleepnet Corporation · Oct 1996