Cleared Special

K102468 - ZOLL PROPAQ MD

K102468 is an FDA 510(k) clearance for ZOLL PROPAQ MD, manufactured by Zoll Medical Corporation, World Wide Headquarters. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Special 510(k) pathway after a 31-day FDA review.

K102468 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
31d
Days
Class 2
Risk

K102468 is an FDA 510(k) clearance for the ZOLL PROPAQ MD. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Zoll Medical Corporation, World Wide Headquarters (Chelsmford, US). The FDA issued a Cleared decision on September 30, 2010 after a review of 31 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. 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. Low regulatory complexity profile. 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 - K102468

510(k) Number K102468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date September 30, 2010
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 122
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K102468.
EURO DEFI PADS ADULT
K103783 · Fiab Spa · Jun 2011
CARDIO MED
K103334 · Cardio Medical Products, Inc. · Jan 2011
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
K103159 · Cardio Medical Products, Inc. · Jan 2011
ZOLL PROPAQ MD
K100654 · Zoll Medical Corporation, World Wide Headquarters · Jul 2010
HEART SYNC PEDIATRIC, MODEL PED-100
K081442 · Heart Sync, LLC · Sep 2008
ZOLL R SERIES
K081574 · ZOLL Medical Corporation · Sep 2008