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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K161768.
AutoPulse NXT Resuscitation System
K221700 · Zoll Circulation, Inc. · Mar 2023
RMU-2000 Automated Chest Compression System
K211289 · Defibtech, LLC · Nov 2021
LUCAS 3 Chest Compression System
K173553 · Jolife AB · Feb 2018
ROSC-U Mini Chest Compressor (RMCC)
K153628 · Resuscitation International, LLC · Jan 2016
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809 · Defibtech, LLC · Oct 2014
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
K112998 · Zoll Circulation · Mar 2012
K161768 · LUCAS 3 Chest Compression System
Download PDF FDA Summary Jolife AB