Cleared Traditional

K040726 - VENTLAB NASAL CPAP CANNULA

K040726 is an FDA 510(k) clearance for VENTLAB NASAL CPAP CANNULA, manufactured by Ventlab Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K040726 · Ventlab Corp. · Anesthesiology device
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Jun 2004
Decision
73d
Days
Class 2
Risk

K040726 is an FDA 510(k) clearance for the VENTLAB NASAL CPAP CANNULA. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventlab Corp. devices

FDA 510(k) Submission Details - K040726

510(k) Number K040726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2004
Decision Date June 03, 2004
Days to Decision 73 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
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 287
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K040726.
RESMED S8 PIONEER CPAP SYSTEM
K041209 · Resmed, Ltd. · Jul 2004
IMASK TM
K041309 · Vital Signs, Inc. · Jun 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941 · Fisher &Paykel Healthcare , Ltd. · Jun 2004
RESCONTROL II
K040944 · Resmed, Ltd. · Jun 2004
RESCAN
K034033 · Resmed, Ltd. · May 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
K040506 · Fisher &Paykel Healthcare , Ltd. · May 2004