Cleared Traditional

K103334 - CARDIO MED

K103334 is an FDA 510(k) clearance for CARDIO MED, 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 64-day FDA review.

K103334 · Cardio Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
64d
Days
Class 2
Risk

K103334 is an FDA 510(k) clearance for the CARDIO MED. 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 January 18, 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 870.5300 - 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: 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 - K103334

510(k) Number K103334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date January 18, 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.

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 150
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K103334.
ZOLL E SERIES ALS
K140502 · ZOLL Medical Corporation · Nov 2014
CARDIOMED
K103651 · Cardio Medical Products, Inc. · Oct 2011
EURO DEFI PADS ADULT
K103783 · Fiab Spa · Jun 2011
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
K103159 · Cardio Medical Products, Inc. · Jan 2011
ZOLL PROPAQ MD
K102468 · Zoll Medical Corporation, World Wide Headquarters · Sep 2010
ZOLL PROPAQ MD
K100654 · Zoll Medical Corporation, World Wide Headquarters · Jul 2010
K103334 · CARDIO MED
Download PDF FDA Summary Cardio Medical Produc…