Sim&Cure: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sim&Cure” (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 days. Since 2017 the median was 148 days, against 158 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 |
|---|---|---|
| 2019 | 1 | 250 |
| 2020 | 1 | 136 |
| 2021 | 0 | — |
| 2022 | 1 | 181 |
| 2023 | 1 | 147 |
| 2024 | 1 | 148 |
| 2025 | 1 | 89 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sim&Cure took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Sim&Cure 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253122 | Sim&Size | PZO | 2025-12-23 | 89 |
| K242124 | Sim&Size | PZO | 2024-12-14 | 148 |
| K222664 | Sim&Size | PZO | 2023-01-27 | 147 |
| K212373 | Sim&Size | PZO | 2022-01-27 | 181 |
| K202322 | Sim&Size | PZO | 2020-12-31 | 136 |
| K190049 | Sim&Size | PZO | 2019-09-17 | 250 |
Recalls
openFDA lists no recalls under a recalling firm named Sim&Cure.
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 Sim&Cure is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07433075: Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study. (Recruiting, started 2026-04-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sim&Cure?
FDA lists 6 510(k) clearances under the applicant name “Sim&Cure” (first 2019, latest 2025), 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 Sim&Cure?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sim&Cure is 148 days. Since 2017: 148 days, versus 158 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sim&Cure?
The most frequent FDA product codes under this applicant name are PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices, 6).
Next steps
- See all 6 Sim&Cure clearances with predicates and recalls
- Run predicate analysis for product code PZO, Sim&Cure'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.