LUCAS 2— 510(k) K090422
Substantially EquivalentJolife AB
FDA 510(k) clearance K090422 for LUCAS 2, Substantially Equivalent on 2009-06-17. Applicant: Jolife AB. Device class: 2.
Clearance details
- Applicant
- Jolife AB
- Product code
- Code DRM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code DRM
view allMore clearances from Jolife AB
view allAdverse events under product code DRM
product code DRM- Death
- 82
- Injury
- 126
- Malfunction
- 4,539
- Total
- 4,747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090422
K-number listed on FDA's recall record- Z-2161-2026 — 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 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 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 breathing and pulse, and loss of consciousness.
- Z-1998-2025 — 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 breathing and pulse, and loss of consciousness.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090422.
Data sourced from openFDA. This site is unofficial and independent of the FDA.