Cleared Traditional

BOUSSIGNAC C.P.A.P. DEVICE (K013884) - FDA 510(k) Clearance

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

K013884 · Vygon SA · Anesthesiology device
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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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K013884.
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
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COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · Respironics, Inc. · Mar 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · Puritan Bennett Corp. · Jan 1990
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988