Cleared Traditional

K040657 - BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80

K040657 is an FDA 510(k) clearance for BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, manufactured by Vygon SA. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040657 · Vygon SA · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
90d
Days
Class 2
Risk

K040657 is an FDA 510(k) clearance for the BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Vygon SA (Temecula, US). The FDA issued a Cleared decision on June 10, 2004 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 868.5730 - 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.

FDA 510(k) Submission Details - K040657

510(k) Number K040657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date June 10, 2004
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.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 238
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K040657.
WELL LEAD ENDOTRACHEAL TUBE
K042683 · Well Lead Medical Instruments · Feb 2005
PLASIATEK ACTUATOR
K041917 · Plasiatek, LLC · Jan 2005
RUSCH EASY TUBE
K043205 · Teleflex Medical · Jan 2005
ENDOFLEX TRACHEAL TUBE
K031794 · Merlyn Associates, Inc. · Mar 2004
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
K032112 · Portex , Ltd. · Jan 2004
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
K040657 · BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
Download PDF FDA Summary Vygon SA