ClearanceBrief
Company ยท US

Jolife AB

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2018. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
DRMCompressor, Cardiac, External8

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 8, 2018K173553LUCAS 3 Chest Compression System
Jolife AB, SE
DRM
Nov 9, 2016K161768LUCAS 3 Chest Compression System
Jolife AB, SE
DRM
Jun 17, 2009K090422LUCAS 2
Jolife AB
DRM
Sep 28, 2006K062401MODIFICATION TO LUCAS
Jolife AB
DRM
Feb 1, 2006K053403LUCAS
Jolife AB
DRM

Latest recalls

DateFirm and productCodeLinked 510(k)
May 11, 2026Jolife AB
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1
Open, Classified
DRMK090422
K161768
Jun 20, 2025Jolife AB
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous brea
Open, Classified
DRMK090422
K161768
Mar 16, 2011Jolife AB
LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFI
Terminated
DRMK090422
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