DreaMed Diabetes, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “DreaMed Diabetes, Ltd.” (first 2019, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 86 days, against 102 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 | 57 |
| 2020 | 1 | 86 |
| 2021 | 1 | 215 |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 243 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DreaMed Diabetes, Ltd. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QCC | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | 5 | 4 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 1 | 1 |
Review panels
Most recent DreaMed Diabetes, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260062 | MODI System | QRX | 2026-09-08 | 243 |
| K232722 | endo.digital Platform | QCC | 2023-10-03 | 28 |
| K210561 | Advisor Pro Platform | QCC | 2021-09-28 | 215 |
| K201476 | DreaMed Advisor Pro | QCC | 2020-08-28 | 86 |
| K191370 | DreaMed Advisor Pro | QCC | 2019-07-18 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170043 | De Novo | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | 2018-06-12 |
Recalls
openFDA lists no recalls under a recalling firm named DreaMed Diabetes, 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.
Device clinical trials
An industry sponsor named DreaMed Diabetes, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04043260: DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy (Completed, started 2019-11-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under DreaMed Diabetes, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “DreaMed Diabetes, Ltd.” (first 2019, latest 2026), 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 DreaMed Diabetes, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name DreaMed Diabetes, Ltd. is 86 days. Since 2017: 86 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DreaMed Diabetes, Ltd.?
The most frequent FDA product codes under this applicant name are QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals, 5); QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator, 1).
Next steps
- See all 5 DreaMed Diabetes, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QCC, DreaMed Diabetes, 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.