Scopio Labs , Ltd.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Scopio Labs , Ltd.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 140 days. Since 2017 the median was 140 days, against 140 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2020 | 1 | 140 |
| 2021 | 0 | — |
| 2022 | 1 | 119 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 270 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scopio Labs , Ltd. took a median 140 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 | 3 | 3 |
| SAL | Device, Automated Cell Locating, Bone Marrow | 1 | 0 |
Review panels
- Hematology (4)
Most recent Scopio Labs , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | JOY | 2025-06-27 | 270 |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | JOY | 2022-05-03 | 119 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | JOY | 2020-10-02 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230034 | De Novo | Device, Automated Cell Locating, Bone Marrow | 2024-03-22 |
Recalls
openFDA lists no recalls under a recalling firm named Scopio Labs , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Scopio Labs , Ltd.?
FDA lists 3 510(k) clearances under the applicant name “Scopio Labs , Ltd.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes 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 Scopio Labs , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scopio Labs , Ltd. is 140 days. Since 2017: 140 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Scopio Labs , Ltd.?
The most frequent FDA product codes under this applicant name are JOY (Device, Automated Cell-Locating, 3); SAL (Device, Automated Cell Locating, Bone Marrow, 1).
Next steps
- See all 3 Scopio Labs , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JOY, Scopio Labs , Ltd.'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.