Cleared Traditional

K141756 - INFINITY EXPLORER SOFTWARE

K141756 is an FDA 510(k) clearance for INFINITY EXPLORER SOFTWARE, manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K141756 · Draeger Medical Systems, Inc. · Cardiovascular device
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Dec 2014
Decision
165d
Days
Class 2
Risk

K141756 is an FDA 510(k) clearance for the INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on December 12, 2014 after a review of 165 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

FDA 510(k) Submission Details - K141756

510(k) Number K141756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2014
Decision Date December 12, 2014
Days to Decision 165 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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