Cleared Traditional

K013884 - BOUSSIGNAC C.P.A.P. DEVICE

K013884 is an FDA 510(k) clearance for BOUSSIGNAC C.P.A.P. DEVICE, manufactured by Vygon SA. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K013884 · Vygon SA · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
424d
Days
Class 2
Risk

K013884 is an FDA 510(k) clearance for the BOUSSIGNAC C.P.A.P. DEVICE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Vygon SA (Temecula, US). The FDA issued a Cleared decision on January 21, 2003 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Vygon SA devices

FDA 510(k) Submission Details - K013884

510(k) Number K013884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date January 21, 2003
Days to Decision 424 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 140d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 56
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K013884.
O_TWO CPAP SYSTEM
K112546 · O-Two Medical Technologies, Inc. · Dec 2011
WATERPAP VALVE
K110713 · Airways Development, LLC · Sep 2011
NEOPIP PATIENT CIRCUIT WITH PEEP
K103833 · Neoforce Group, Inc. · Apr 2011
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
K982283 · Caradyne, Ltd. · Mar 1999
EMS PEEP VALVES- ADJUSTABLE
K983920 · Engineered Medical Systems · Jan 1999
0-20 CM H20 PEEP VALVE
K981415 · Cheen Houng Ent. Co. , Ltd. · Jul 1998