510(k) K161768 ยท DRM Compressor, Cardiac, External
LUCAS 3 Chest Compression System
| Applicant | Jolife AB, Lund, SE |
| Decision | Substantially Equivalent, Nov 9, 2016 |
| Received | Jun 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2026 | Jolife 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 |
DRM | None listed |
| Jun 20, 2025 | Jolife 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 |
DRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.