Cleared Traditional

K942530 - ART-ASSIST MODEL AA-1000

K942530 is the FDA 510(k) clearance for ART-ASSIST MODEL AA-1000 by Aci Medical, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 642-day FDA review.

K942530 · Aci Medical, Inc. · Cardiovascular device
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Feb 1996
Decision
642d
Days
Class 2
Risk

K942530 is an FDA 510(k) clearance for the ART-ASSIST MODEL AA-1000. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Aci Medical, Inc. (San Marcos, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 642 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Aci Medical, Inc. devices

Submission Details

510(k) Number K942530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1994
Decision Date February 28, 1996
Days to Decision 642 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
517d slower than avg
Panel avg: 125d · This submission: 642d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 99
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