Cleared Traditional

K053403 - LUCAS

K053403 is an FDA 510(k) clearance for 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 57-day FDA review.

K053403 · Jolife AB · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
57d
Days
Class 2
Risk

K053403 is an FDA 510(k) clearance for the 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 February 1, 2006 after a review of 57 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.

FDA 510(k) Submission Details - K053403

510(k) Number K053403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2005
Decision Date February 01, 2006
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
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 30
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K053403.
AUTOPULSE RESUSCITATION SYSTEM MODEL100
K063602 · Zoll Circulation · Dec 2006
MODIFICATION TO LUCAS
K062401 · Jolife AB · Sep 2006
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K062119 · Medical Products Mfg., LLC · Sep 2006
ENERTRON CPR JACK
K024215 · Enertron Engineering Co. · May 2004
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K040453 · Revivant Corp. · Mar 2004
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · Revivant Corp. · Nov 2003
K053403 · LUCAS
Download PDF FDA Summary Jolife AB