Cleared Traditional

K161768 - LUCAS 3 Chest Compression System

K161768 is an FDA 510(k) clearance for LUCAS 3 Chest Compression System, 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 135-day FDA review.

K161768 · Jolife AB · Cardiovascular device
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Nov 2016
Decision
135d
Days
Class 2
Risk

K161768 is an FDA 510(k) clearance for the LUCAS 3 Chest Compression System. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Jolife AB (Lund, SE). The FDA issued a Cleared decision on November 9, 2016 after a review of 135 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 - K161768

510(k) Number K161768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date November 09, 2016
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
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 K161768.
AutoPulse NXT Resuscitation System
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RMU-2000 Automated Chest Compression System
K211289 · Defibtech, LLC · Nov 2021
LUCAS 3 Chest Compression System
K173553 · Jolife AB · Feb 2018
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HUNTLEIGH FLOWPAC FP2000
K871272 · Huntleigh Technology, Inc. · Jun 1987
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734 · Medasonics, Inc. · Feb 1986