Cleared Traditional

K091732 - VRLXP, MODEL XP (FDA 510(k) Clearance)

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

K091732 · Deep Breeze , Ltd. · Anesthesiology device
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Mar 2010
Decision
266d
Days
Class 2
Risk

K091732 is an FDA 510(k) clearance for the VRLXP, MODEL XP. Classified as Lung Sound Monitor (product code OCR), Class II - Special Controls.

Submitted by Deep Breeze , Ltd. (Washington, US). The FDA issued a Cleared decision on March 4, 2010 after a review of 266 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.1875 - 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.

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Submission Details

510(k) Number K091732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date March 04, 2010
Days to Decision 266 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
127d slower than avg
Panel avg: 139d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCR Lung Sound Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
Definition The Lung Sound Monitor Is Intended For Use In Monitoring And Recording Lung Sounds.
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.