Cleared Traditional

K140548 - CORCAM HEART MONITOR

K140548 is an FDA 510(k) clearance for CORCAM HEART MONITOR, manufactured by Corcam Technologia, SA. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K140548 · Corcam Technologia, SA · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
80d
Days
Class 2
Risk

K140548 is an FDA 510(k) clearance for the CORCAM HEART MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Corcam Technologia, SA (New York, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 - K140548

510(k) Number K140548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date May 23, 2014
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 367
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K140548.
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K121197 · Preventice, Inc. · Aug 2012
K140548 · CORCAM HEART MONITOR
Download PDF FDA Summary Corcam Technologia, SA