Cleared Traditional

K061495 - VR LUNG ELECTROSONOGRAPH (FDA 510(k) Clearance)

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

K061495 · Deep Breeze , Ltd. · Anesthesiology device
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Jul 2007
Decision
413d
Days
Class 2
Risk

K061495 is an FDA 510(k) clearance for the VR LUNG ELECTROSONOGRAPH. 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 July 18, 2007 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Deep Breeze , Ltd. devices

Submission Details

510(k) Number K061495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date July 18, 2007
Days to Decision 413 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
274d slower than avg
Panel avg: 139d · This submission: 413d
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.