Mahana Therapeutics, Inc.: FDA clearances and approvals
Mahana Therapeutics, Inc. has 1 FDA 510(k) clearance (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 29 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 29 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Mahana Therapeutics, Inc.'s cleared 510(k)s took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms | 2 | 1 |
Review panels
Most recent Mahana Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) | QMY | 2021-06-02 | 29 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200029 | De Novo | Computerized Behavioral Therapy Device For Treating Symptoms | 2020-11-25 |
Recalls
openFDA lists no recalls under a recalling firm named Mahana Therapeutics, Inc..
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.
Device clinical trials
Mahana Therapeutics, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05696158: Mahana Tinnitus Pilot (Completed, started 2022-12-19)
- NCT05333926: MHNA-001 for Young Adults With IBS (Completed, started 2022-04-01)
Frequently asked questions
How many FDA 510(k) clearances does Mahana Therapeutics, Inc. have?
Mahana Therapeutics, Inc. has 1 FDA 510(k) clearance (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Mahana Therapeutics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mahana Therapeutics, Inc.'s cleared 510(k)s is 29 days.
What devices does Mahana Therapeutics, Inc. make?
Its most frequent FDA product codes are QMY (Computerized Behavioral Therapy Device For Treating Symptoms, 2).
Has Mahana Therapeutics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mahana Therapeutics, Inc. Related entities may recall under other names.
Next steps
- See all 1 Mahana Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QMY, Mahana Therapeutics, Inc.'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.