Cleared Traditional

EVERON (K082465) - FDA 510(k) Clearance

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

K082465 · Earlysense, Ltd. · Anesthesiology device
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Mar 2009
Decision
210d
Days
Class 2
Risk

K082465 is an FDA 510(k) clearance for the EVERON. 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 March 25, 2009 after a review of 210 days - an extended review cycle.

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

Submission Details

510(k) Number K082465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2008
Decision Date March 25, 2009
Days to Decision 210 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
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K082465.
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
K180079 · Hill-Rom, Inc. · May 2018
EarlySense Bed Sensing Unit
K171836 · Earlysense, Ltd. · Jan 2018
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995