Cleared Traditional

K081442 - HEART SYNC PEDIATRIC, MODEL PED-100

K081442 is an FDA 510(k) clearance for HEART SYNC PEDIATRIC, manufactured by Heart Sync, LLC. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K081442 · Heart Sync, LLC · Cardiovascular device
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Sep 2008
Decision
125d
Days
Class 2
Risk

K081442 is an FDA 510(k) clearance for the HEART SYNC PEDIATRIC, MODEL PED-100. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Heart Sync, LLC (Ann Arbor, US). The FDA issued a Cleared decision on September 24, 2008 after a review of 125 days - within the typical 510(k) review window.

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 Heart Sync, LLC devices

FDA 510(k) Submission Details - K081442

510(k) Number K081442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date September 24, 2008
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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)

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