Jolife AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Jolife AB” (first 2006, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 135 |
| 2017 | 0 | — |
| 2018 | 1 | 84 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jolife AB took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Jolife AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173553 | LUCAS 3 Chest Compression System | DRM | 2018-02-08 | 84 |
| K161768 | LUCAS 3 Chest Compression System | DRM | 2016-11-09 | 135 |
| K090422 | LUCAS 2 | DRM | 2009-06-17 | 119 |
| K062401 | MODIFICATION TO LUCAS | DRM | 2006-09-28 | 43 |
| K053403 | LUCAS | DRM | 2006-02-01 | 57 |
Recalls
3 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2026-04-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Jolife AB is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00609778: A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study (Completed, started 2008-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jolife AB?
FDA lists 5 510(k) clearances under the applicant name “Jolife AB” (first 2006, latest 2018), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jolife AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jolife AB is 84 days.
Which FDA product codes appear under Jolife AB?
The most frequent FDA product codes under this applicant name are DRM (Compressor, Cardiac, External, 5).
Next steps
- See all 5 Jolife AB clearances with predicates and recalls
- Run predicate analysis for product code DRM, Jolife AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.