Cleared Traditional

K110810 - ANASCIENT BREATH MONITOR

K110810 is an FDA 510(k) clearance for ANASCIENT BREATH MONITOR, manufactured by Invoy Technologies, LLC. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K110810 · Invoy Technologies, LLC · Anesthesiology device
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Jun 2011
Decision
90d
Days
Class 2
Risk

K110810 is an FDA 510(k) clearance for the ANASCIENT BREATH MONITOR. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Invoy Technologies, LLC (Chandler, US). The FDA issued a Cleared decision on June 21, 2011 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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.

FDA 510(k) Submission Details - K110810

510(k) Number K110810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date June 21, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 Consultant

Intertek Testing Services
BHAVESH V SHETH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZL Computer, Oxygen-uptake

All 21
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