Cleared Special

MODIFICATION TO: POCKETVIEW ECG SOFTWARE (K013311) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013311 · Micromedical Industries, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
91d
Days
Class 2
Risk

K013311 is an FDA 510(k) clearance for the MODIFICATION TO: POCKETVIEW ECG SOFTWARE. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Micromedical Industries, Ltd. (Labrador, Queensland, AU). The FDA issued a Cleared decision on January 3, 2002 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micromedical Industries, Ltd. devices

Submission Details

510(k) Number K013311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date January 03, 2002
Days to Decision 91 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 133
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K013311.
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K012016 · Siemens Medical Solutions USA, Inc. · Jul 2001
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243 · Siemens Medical Solutions USA, Inc. · Dec 2000