Cleared Traditional

K062401 - MODIFICATION TO LUCAS

K062401 is an FDA 510(k) clearance for MODIFICATION TO LUCAS, 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 43-day FDA review.

K062401 · Jolife AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
43d
Days
Class 2
Risk

K062401 is an FDA 510(k) clearance for the MODIFICATION TO LUCAS. 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 September 28, 2006 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jolife AB devices

FDA 510(k) Submission Details - K062401

510(k) Number K062401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date September 28, 2006
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 K062401.
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