Cleared Traditional

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR (K011461) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 19
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K011461.
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K971194 · Nihon Kohden America, Inc. · Jul 1997