510(k) Report

FDA applicant

Jolife AB

Washington, DC5 decisions2006–20183 recalls

FDA records 5 decisions for Jolife AB (Washington, DC) from 2006 to 2018: 5 510(k) clearances. All are in product code DRM (Compressor, Cardiac, External). Its devices cite 11 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Jolife AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12016: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2011: 12025: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Jolife AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRMCompressor, Cardiac, External5decisions

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090422LUCAS 2Jolife AB · 20093cite it
  • K062401Modification to LucasJolife AB · 20061cites it
  • K161768LUCAS 3 Chest Compression SystemJolife AB · 20161cites it
  • K173553LUCAS 3 Chest Compression SystemJolife AB · 20181cites it
  • K053403LUCASJolife AB · 20061cites it

What has FDA decided for it lately?

  • K173553LUCAS 3 Chest Compression SystemJolife AB · 2018
  • K161768LUCAS 3 Chest Compression SystemJolife AB · 20162 recalls
  • K090422LUCAS 2Jolife AB · 20093 recalls
  • K062401Modification to LucasJolife AB · 2006
  • K053403LUCASJolife AB · 2006

All 5 as Jolife AB →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K090422LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code…Apr 13, 2026Class II
  • K161768LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external…May 21, 2025Class II
  • K090422LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part…Feb 8, 2011