Cleared Traditional

K131379 - EARLYSENSE

K131379 is an FDA 510(k) clearance for EARLYSENSE, 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 218-day FDA review.

K131379 · Earlysense, Ltd. · Anesthesiology device
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Dec 2013
Decision
218d
Days
Class 2
Risk

K131379 is an FDA 510(k) clearance for the EARLYSENSE. 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 December 18, 2013 after a review of 218 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 - K131379

510(k) Number K131379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date December 18, 2013
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
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 K131379.
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
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K132320 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 2014
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
K122223 · Philips Medizin Systeme Boeblingen GmbH · Apr 2013
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
PNEUMOTHERML, MODEL: 5800
K092685 · Salter Labs · Nov 2009