Cleared Special

K060254 - MODIFICATION TO INFINITY EXPLORER

K060254 is an FDA 510(k) clearance for MODIFICATION TO INFINITY EXPLORER, manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 62-day FDA review.

K060254 · Draeger Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
62d
Days
Class 2
Risk

K060254 is an FDA 510(k) clearance for the MODIFICATION TO INFINITY EXPLORER. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on April 4, 2006 after a review of 62 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. 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. Low regulatory complexity profile. 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 - K060254

510(k) Number K060254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date April 04, 2006
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
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 Peers - MSX System, Network And Communication, Physiological Monitors

All 73
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