Cleared Traditional

K071915 - CPAP MASK

K071915 is an FDA 510(k) clearance for CPAP MASK, manufactured by Arcimed Laboratories, LLC. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K071915 · Arcimed Laboratories, LLC · Anesthesiology device
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May 2008
Decision
308d
Days
Class 2
Risk

K071915 is an FDA 510(k) clearance for the CPAP MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Arcimed Laboratories, LLC (Bonita Springs, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Arcimed Laboratories, LLC devices

FDA 510(k) Submission Details - K071915

510(k) Number K071915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2007
Decision Date May 14, 2008
Days to Decision 308 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
168d slower than avg
Panel avg: 140d · This submission: 308d
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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K071915.
MODIFICATION TO MIRAGE MICRO
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COMFORTGEL FULL FACE MASK
K073600 · Respironics Inc., Sleep & Home Respiratory Group · Apr 2008
S8 ESCAPE II
K080079 · Resmed, Ltd. · Apr 2008
VPAP ST
K080131 · Resmed, Ltd. · Apr 2008