Cleared Traditional

K103651 - CARDIOMED

K103651 is an FDA 510(k) clearance for CARDIOMED, manufactured by Cardio Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K103651 · Cardio Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
294d
Days
Class 2
Risk

K103651 is an FDA 510(k) clearance for the CARDIOMED. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardio Medical Products, Inc. (Rockaway, US). The FDA issued a Cleared decision on October 4, 2011 after a review of 294 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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.

View all Cardio Medical Products, Inc. devices

FDA 510(k) Submission Details - K103651

510(k) Number K103651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2010
Decision Date October 04, 2011
Days to Decision 294 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 125d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 108
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K103651.
Tempus LS - Manual
K200849 · Remote Diagnostic Technologies, Ltd. A Philips Company · Jul 2020
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
K182503 · Physio-Control, Inc. · Jun 2019
ZOLL E SERIES ALS
K140502 · ZOLL Medical Corporation · Nov 2014
ZOLL PROPAQ MD
K102468 · Zoll Medical Corporation, World Wide Headquarters · Sep 2010
ZOLL PROPAQ MD
K100654 · Zoll Medical Corporation, World Wide Headquarters · Jul 2010
ZOLL R SERIES
K081574 · ZOLL Medical Corporation · Sep 2008