Cleared Special

K120865 - RSCRIBE ELECTROCARDIOGRAPH

K120865 is an FDA 510(k) clearance for RSCRIBE ELECTROCARDIOGRAPH, manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 119-day FDA review.

K120865 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
119d
Days
Class 2
Risk

K120865 is an FDA 510(k) clearance for the RSCRIBE ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 19, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K120865

510(k) Number K120865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2012
Decision Date July 19, 2012
Days to Decision 119 days
Submission Type Special
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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K120865.
DIGITAL ELECTROCARDIOGRAPH
K122712 · Shenzhen Biocare Electronics Co., Ltd. · Oct 2012
ELI 280 ELECTROCARDIOGRAPH
K122073 · Mortara Instrument, Inc. · Aug 2012
HANDHELD ECG MONITOR
K112622 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2012
CARDIO 7
K113306 · Bionet Co., Ltd. · Jul 2012
HEARTCHECK ECG PEN WITH GEMS HOME
K121009 · Cardiocomm Solutions, Inc. · May 2012
ELECTROCARDIOGRAPH
K113485 · Shenzhen Carewell Electronics Co., Ltd. · Apr 2012
K120865 · RSCRIBE ELECTROCARDIOGRAPH
Download PDF FDA Summary Mortara Instrument, I…