Cleared Traditional

INFINITY TELESMART TELEMETRY SYSTEM (K061379) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061379 · Draeger Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
275d
Days
Class 2
Risk

K061379 is an FDA 510(k) clearance for the INFINITY TELESMART TELEMETRY SYSTEM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on February 16, 2007 after a review of 275 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Draeger Medical Systems, Inc. devices

Submission Details

510(k) Number K061379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2006
Decision Date February 16, 2007
Days to Decision 275 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 125d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 161
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K061379.
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE
K071020 · Ge Healthcare · Jun 2007
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
K071073 · Ge Medical Systems Information Technologies · May 2007
HYPERVISOR VI CENTRAL MONITORING SYSTEM
K062194 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2007
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
K062098 · Datascope Corp. · Feb 2007
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
K062324 · Ge Healthcare · Dec 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
K062576 · Ge Healthcare · Sep 2006