Cleared Traditional

K141615 - ENDOPHYS BLOOD PRESSURE MONITOR

K141615 is an FDA 510(k) clearance for ENDOPHYS BLOOD PRESSURE MONITOR, manufactured by Endophys, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K141615 · Endophys, Inc. · Cardiovascular device
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Jan 2015
Decision
205d
Days
Class 2
Risk

K141615 is an FDA 510(k) clearance for the ENDOPHYS BLOOD PRESSURE MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Endophys, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 7, 2015 after a review of 205 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Endophys, Inc. devices

FDA 510(k) Submission Details - K141615

510(k) Number K141615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date January 07, 2015
Days to Decision 205 days
Submission Type Traditional
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
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 51
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