Cleared Abbreviated

K113105 - TEMPUSIC PATIENT MONITOR

K113105 is an FDA 510(k) clearance for TEMPUSIC PATIENT MONITOR, manufactured by Remote Diagnostic Technologies , Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K113105 · Remote Diagnostic Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
56d
Days
Class 2
Risk

K113105 is an FDA 510(k) clearance for the TEMPUSIC PATIENT MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Remote Diagnostic Technologies , Ltd. (Hampshire, GB). The FDA issued a Cleared decision on December 15, 2011 after a review of 56 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K113105

510(k) Number K113105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date December 15, 2011
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 Consultant

Intertek Testing Services
WILLIAM SAMMONS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K113105.
CONNEX WORKSTATION
K120343 · Welch Allyn, Inc. · Feb 2012
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
K113183 · Shanghai 3f Electronics Co, Ltd. · Feb 2012
MINI-MEDIC
K113165 · Athena Gtx · Feb 2012
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · Welch Allyn, Inc. · Nov 2011
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
K110463 · Norav Medical , Ltd. · Nov 2011
OMNI PATIENT MONITOR
K112329 · Infinium Medical · Sep 2011