Cleared Special

K060039 - INFINITY DELTA AND KAPPA SERIES MONITOR...

K060039 is an FDA 510(k) clearance for INFINITY DELTA AND KAPPA SERIES MONITOR..., manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 96-day FDA review.

K060039 · Draeger Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
96d
Days
Class 2
Risk

K060039 is an FDA 510(k) clearance for the INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS. 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 April 12, 2006 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Draeger Medical Systems, Inc. devices

FDA 510(k) Submission Details - K060039

510(k) Number K060039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date April 12, 2006
Days to Decision 96 days
Submission Type Special
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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

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 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K060039.
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
K061052 · Philips Medical Systems North America, Inc. · May 2006
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
K060135 · Mortara Instrument, Inc. · May 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
K061185 · Ge Healthcare · May 2006
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K060223 · Draeger Medical Systems, Inc. · Apr 2006
TRAM MODULE
K053121 · Ge Healthcare · Apr 2006
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
K053484 · Draeger Medical Systems, Inc. · Feb 2006