Cleared Special

K033694 - INFINITY MODULAR MONITORS VF4 MODIFICATIONS

K033694 is an FDA 510(k) clearance for INFINITY MODULAR MONITORS VF4 MODIFICATIONS, 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 119-day FDA review.

K033694 · Draeger Medical Systems, Inc. · Cardiovascular device
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Mar 2004
Decision
119d
Days
Class 2
Risk

K033694 is an FDA 510(k) clearance for the INFINITY MODULAR MONITORS VF4 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 March 22, 2004 after a review of 119 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 - K033694

510(k) Number K033694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date March 22, 2004
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 K033694.
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
K033957 · Draeger Medical Systems, Inc. · May 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
K040955 · Philips Medical Systems, Inc. · May 2004
INFINITY GAMMA
K041087 · Draeger Medical Systems, Inc. · May 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
K040357 · Philips Medical Systems, Inc. · Mar 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · Philips Medizin Systeme Boeblingen GmbH · Mar 2004
ENVOY PATIENT MONITOR
K030722 · Mennen Medical, Inc. · Feb 2004