Cleared Special

K121885 - EARLYSENSE CENTRAL DISPLAY SYSTEM

K121885 is an FDA 510(k) clearance for EARLYSENSE CENTRAL DISPLAY SYSTEM, manufactured by Earlysense, Ltd.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 74-day FDA review.

K121885 · Earlysense, Ltd. · Cardiovascular device
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Sep 2012
Decision
74d
Days
Class 2
Risk

K121885 is an FDA 510(k) clearance for the EARLYSENSE CENTRAL DISPLAY SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Earlysense, Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on September 10, 2012 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Earlysense, Ltd. devices

FDA 510(k) Submission Details - K121885

510(k) Number K121885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2012
Decision Date September 10, 2012
Days to Decision 74 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 118
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