Cleared Traditional

K090422 - LUCAS 2

K090422 is an FDA 510(k) clearance for LUCAS 2, manufactured by Jolife AB. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K090422 · Jolife AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
119d
Days
Class 2
Risk

K090422 is an FDA 510(k) clearance for the LUCAS 2. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Jolife AB (Washington, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - 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 Jolife AB devices

FDA 510(k) Submission Details - K090422

510(k) Number K090422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2009
Decision Date June 17, 2009
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
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 - DRM Compressor, Cardiac, External

All 11
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K090422.
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K854734 · Medasonics, Inc. · Feb 1986