Data / Medical devices / Canada / Flosonics Medical (r/A 1929803 Ontario Corp.)
Flosonics Medical (r/A 1929803 Ontario Corp.): FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Flosonics Medical (r/A 1929803 Ontario Corp.) is registered with the FDA (registration 3015139886) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 24, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015139886
- Address
- 325 Front St W Floor 4, Toronto Ontario, Canada, M5V 2Y1
- Owner or operator
- Flosonics Medical (R/A 1929803 Ontario Corp.) (10065763)
- Roles
- Exporter to the US, Manufacturer, Reprocessor
- First device listed
- April 9, 2020
- Registered through
- 2026
- Brand names listed
- FloPatch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Exporter to the US, Manufacturer, Reprocessor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2020 | K200337 | FloPatch (FP120) | DPW | Substantially Equivalent | Flosonics Medical (R/A 1929803 Ontario Corp.) | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 7, 2025 | 97427 | Class III | Ongoing | FloPatch FP120, REF: FP120-FOT01-005 | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. | accessdata.fda.gov |
Compare with other makers
Updated September 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.