Cleared Traditional

K011461 - ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR

K011461 is an FDA 510(k) clearance for ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR, manufactured by Access Cardiosystems, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K011461 · Access Cardiosystems, Inc. · Cardiovascular device
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May 2002
Decision
379d
Days
Class 2
Risk

K011461 is an FDA 510(k) clearance for the ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Access Cardiosystems, Inc. (Concord, US). The FDA issued a Cleared decision on May 28, 2002 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Access Cardiosystems, Inc. devices

FDA 510(k) Submission Details - K011461

510(k) Number K011461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date May 28, 2002
Days to Decision 379 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
254d slower than avg
Panel avg: 125d · This submission: 379d
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 115
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K011461.
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