Cleared Traditional

K073582 - VRIICU SYSTEM (FDA 510(k) Clearance)

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

K073582 · Deep Breeze , Ltd. · Anesthesiology device
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Oct 2008
Decision
300d
Days
Class 2
Risk

K073582 is an FDA 510(k) clearance for the VRIICU SYSTEM. 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 October 15, 2008 after a review of 300 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: 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 K073582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2007
Decision Date October 15, 2008
Days to Decision 300 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
161d slower than avg
Panel avg: 139d · This submission: 300d
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.