Cleared Traditional

K111296 - ZOLL RESCUENETLINK

K111296 is an FDA 510(k) clearance for ZOLL RESCUENETLINK, manufactured by Zoll Medical Corporation, World Wide Headquarters. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K111296 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
171d
Days
Class 2
Risk

K111296 is an FDA 510(k) clearance for the ZOLL RESCUENETLINK. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Zoll Medical Corporation, World Wide Headquarters (Chelsmford, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 171 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.

FDA 510(k) Submission Details - K111296

510(k) Number K111296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2011
Decision Date October 27, 2011
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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 118
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