Cleared Traditional

K152911 - EarlySense Insight Sytem

K152911 is an FDA 510(k) clearance for EarlySense Insight Sytem, 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 217-day FDA review.

K152911 · Earlysense, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
217d
Days
Class 2
Risk

K152911 is an FDA 510(k) clearance for the EarlySense Insight Sytem. 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 May 6, 2016 after a review of 217 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 - K152911

510(k) Number K152911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date May 06, 2016
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
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 K152911.
Masimo Acoustic Respiration Sensors, infant and neonate
K173976 · Masimo Corporation · Sep 2018
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
INTELLIVUE CL RESPIRATION POD
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