Cleared Traditional

K141020 - SURVEYOR S4 MOBILE MONITOR

K141020 is an FDA 510(k) clearance for SURVEYOR S4 MOBILE MONITOR, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K141020 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
226d
Days
Class 2
Risk

K141020 is an FDA 510(k) clearance for the SURVEYOR S4 MOBILE MONITOR. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 3, 2014 after a review of 226 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Mortara Instrument, Inc. devices

FDA 510(k) Submission Details - K141020

510(k) Number K141020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2014
Decision Date December 03, 2014
Days to Decision 226 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
101d slower than avg
Panel avg: 125d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 112
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K141020.
VitalWatch Software User Interface
K170973 · Vitalconnect, Inc. · Jun 2017
FFR Link, FFR Signal Processing Module
K170204 · Boston Scientific Corporation · Mar 2017
TelePatch Cardiac Monitor
K161916 · Medicomp, Inc. · Dec 2016
S HEALTH
K132148 · Samsung Electronics Co., Ltd. · Dec 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
K131913 · Philips Medizin Systeme Boeblingen GmbH · Nov 2013
OPTUM TELEHEALTH APPLICATION
K130971 · Optumhealth Care Solutions, Inc. · Oct 2013