Caristo Diagnostics , Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Caristo Diagnostics , Ltd.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 156 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 |
|---|---|---|
| 2020 | 1 | 107 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 205 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Caristo Diagnostics , Ltd. 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 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| SIU | Predictive Indicator For Long-Term Cardiovascular Outcomes | 1 | 0 |
Review panels
- Radiology (2)
- Cardiovascular (1)
Most recent Caristo Diagnostics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242240 | CaRi-Plaque | LLZ | 2025-02-20 | 205 |
| K200274 | CariCloud | LLZ | 2020-05-21 | 107 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250042 | De Novo | Predictive Indicator For Long-Term Cardiovascular Outcomes | 2026-07-28 |
Recalls
openFDA lists no recalls under a recalling firm named Caristo Diagnostics , 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 Caristo Diagnostics , Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Caristo Diagnostics , Ltd.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Caristo Diagnostics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caristo Diagnostics , Ltd. is 156 days.
Which FDA product codes appear under Caristo Diagnostics , Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 2); SIU (Predictive Indicator For Long-Term Cardiovascular Outcomes, 1).
Next steps
- See all 2 Caristo Diagnostics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Caristo Diagnostics , 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.