Cleared Traditional

K130707 - ISIRONA MAGELLAN

K130707 is an FDA 510(k) clearance for ISIRONA MAGELLAN, manufactured by Isirona, LLC. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K130707 · Isirona, LLC · Cardiovascular device
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Nov 2013
Decision
250d
Days
Class 2
Risk

K130707 is an FDA 510(k) clearance for the ISIRONA MAGELLAN. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Isirona, LLC (Nederland, US). The FDA issued a Cleared decision on November 20, 2013 after a review of 250 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 Isirona, LLC devices

FDA 510(k) Submission Details - K130707

510(k) Number K130707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2013
Decision Date November 20, 2013
Days to Decision 250 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
125d slower than avg
Panel avg: 125d · This submission: 250d
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 75
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