CellaVision AB: FDA clearances and approvals
CellaVision AB has 7 FDA 510(k) clearances (first 2001, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time: 146 days. openFDA lists 2 product recalls by a recalling firm named CellaVision AB.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 89 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 224 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, CellaVision AB's cleared 510(k)s took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | 7 | 7 |
Review panels
- Hematology (7)
Most recent CellaVision AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | JOY | 2020-10-16 | 224 |
| K171315 | Advanced RBC Application | JOY | 2017-08-01 | 89 |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | JOY | 2011-09-16 | 357 |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | JOY | 2009-11-20 | 63 |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | JOY | 2008-12-05 | 277 |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | JOY | 2004-02-10 | 62 |
| K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | JOY | 2001-03-15 | 146 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2025-10-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does CellaVision AB have?
CellaVision AB has 7 FDA 510(k) clearances (first 2001, latest 2020), across 1 product code in 1 review panel.
How long does FDA take to clear CellaVision AB's 510(k)s?
The median time from FDA receipt to decision across CellaVision AB's cleared 510(k)s is 146 days.
What devices does CellaVision AB make?
Its most frequent FDA product codes are JOY (Device, Automated Cell-Locating, 7).
Has CellaVision AB had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches CellaVision AB; the most recent began 2025-10-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 CellaVision AB clearances with predicates and recalls
- Run predicate analysis for product code JOY, CellaVision AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.