Jan Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Jan Medical, Inc.” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 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 |
|---|---|---|
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jan Medical, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 30 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POP | Cranial Motion Measurement Device | 2 | 1 |
Review panels
- Neurology (2)
Most recent Jan Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170926 | BrainPulse 1100 | POP | 2017-04-28 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140040 | De Novo | Cranial Motion Measurement Device | 2016-08-01 |
Recalls
openFDA lists no recalls under a recalling firm named Jan Medical, Inc..
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 Jan Medical, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03235271: Pilot Study of Acute Stroke Using the Brainpulse™ (Completed, started 2017-09-10)
- NCT02992795: Unblinded Data Collection Study of Concussion Using BrainPulse (Completed, started 2016-11)
- NCT02812225: Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM) (Completed, started 2016-06)
- NCT02660164: A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion (Completed, started 2015-11)
- NCT02350699: Control Study of Nautilus BrainPulse for the Detection of Concussion (Completed, started 2015-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jan Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Jan Medical, Inc.” (first 2017, latest 2017), plus 1 De Novo decision, 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 Jan Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jan Medical, Inc. is 30 days.
Which FDA product codes appear under Jan Medical, Inc.?
The most frequent FDA product codes under this applicant name are POP (Cranial Motion Measurement Device, 2).
Next steps
- See all 1 Jan Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code POP, Jan Medical, Inc.'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.