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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Invoy Technologies, LLC devices

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
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 Peers - BZL Computer, Oxygen-uptake

All 14
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K110810.
Breezing Med
K200076 · Tf Health Co. · Sep 2020
NICU V'02
K190561 · Cosmed Nordic Aps · Sep 2020
EXPRESS SERIES
K070858 · Medical Graphics Corp. · Apr 2007
MEDGRAPHICS ULTIMA SYSTEM
K061731 · Medical Graphics Corp. · Sep 2006
7250 METABOLIC MONITOR
K924978 · Puritan Bennett Corp. · Sep 1994
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · Datex Division Instrumentarium Corp. · Nov 1993