Cleared Traditional

K082465 - EVERON

K082465 is an FDA 510(k) clearance for EVERON, 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 210-day FDA review.

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

FDA 510(k) Submission Details - K082465

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
Combination Product No
PCCP Authorized No
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.

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 112
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K082465.
EVERON 1.0
K092062 · Earlysense, Ltd. · May 2010
PNEUMOTHERML, MODEL: 5800
K092685 · Salter Labs · Nov 2009
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
K090273 · Kai Sensors, Inc. · Jun 2009
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
K080922 · Salter Labs, Division of Regulatory Affairs · Jul 2008
EARLYSENSE ES-16 SYSTEM
K070375 · Earlysense, Ltd. · Nov 2007
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883 · Gereonics, Inc. · Jun 2007