Biotricity: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biotricity” (first 2016, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 128 days, against 222 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 |
|---|---|---|
| 2016 | 1 | 28 |
| 2017 | 1 | 136 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 119 |
| 2021 | 0 | — |
| 2022 | 2 | 125 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biotricity took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 222 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Biotricity 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222017 | Biotres | MWJ | 2022-07-28 | 20 |
| K211709 | Biotres | MWJ | 2022-01-19 | 230 |
| K201040 | Bioflux Software II | DSH | 2020-07-29 | 119 |
| K172311 | BioFlux Device | DXH | 2017-12-15 | 136 |
| K162571 | Bioflux Software | DSH | 2016-10-13 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Biotricity.
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.
SEC filings
BIOTRICITY INC. (BTCY): EDGAR filings, CIK 1630113. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotricity?
FDA lists 5 510(k) clearances under the applicant name “Biotricity” (first 2016, latest 2022), across 3 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 Biotricity?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotricity is 119 days. Since 2017: 128 days, versus 222 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biotricity?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 2); MWJ (Electrocardiograph, Ambulatory (Without Analysis), 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 5 Biotricity clearances with predicates and recalls
- Run predicate analysis for product code DSH, Biotricity'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.