Cleared Traditional

K120465 - EARLYSENSE (EVERON) SYSTEM

K120465 is an FDA 510(k) clearance for EARLYSENSE (EVERON) SYSTEM, manufactured by Earlysense, Ltd.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K120465 · Earlysense, Ltd. · Anesthesiology device
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Jun 2012
Decision
114d
Days
Class 2
Risk

K120465 is an FDA 510(k) clearance for the EARLYSENSE (EVERON) SYSTEM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Earlysense, Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on June 8, 2012 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Earlysense, Ltd. devices

FDA 510(k) Submission Details - K120465

510(k) Number K120465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2012
Decision Date June 08, 2012
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 78
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K120465.
EarlySense Bed Sensing Unit
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K122223 · Philips Medizin Systeme Boeblingen GmbH · Apr 2013
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
PNEUMOTHERML, MODEL: 5800
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BROWSER (EVENT SOFTWARE) MODEL # 4500E
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