Cleared Traditional

K111215 - ASCOM MOBILE MONITORING GATEWAY (MMG)

K111215 is an FDA 510(k) clearance for ASCOM MOBILE MONITORING GATEWAY (MMG), manufactured by Ascom (Sweden) AB. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K111215 · Ascom (Sweden) AB · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
64d
Days
Class 2
Risk

K111215 is an FDA 510(k) clearance for the ASCOM MOBILE MONITORING GATEWAY (MMG). Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Ascom (Sweden) AB (Goteborg, SE). The FDA issued a Cleared decision on July 5, 2011 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K111215

510(k) Number K111215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2011
Decision Date July 05, 2011
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K111215.
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