Cleared Traditional

K160945 - Endophys Blood Pressure Monitor

K160945 is an FDA 510(k) clearance for Endophys Blood Pressure Monitor, manufactured by Endophys Holdings, LLC. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K160945 · Endophys Holdings, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
174d
Days
Class 2
Risk

K160945 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 Holdings, LLC (Dallas, US). The FDA issued a Cleared decision on September 26, 2016 after a review of 174 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 Holdings, LLC devices

FDA 510(k) Submission Details - K160945

510(k) Number K160945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date September 26, 2016
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K160945.
Endophys Blood Pressure Monitor model BPM-30
K231586 · Endophys Technologies, LLC · Nov 2023
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · Volcano Corporation · Dec 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · Endophys, Inc. · Jan 2015
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · Schiller AG · Aug 2004
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · Radi Medical Systems AB · Dec 2001
ZOLL M SERIES IBP OPERATION
K011865 · Zoll Medical Corp · Jul 2001