Flosonics Medical (R/A 1929803 ONTARIO Corp.)

Toronto Ontario, CA

FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.) appears in FDA device records in Toronto Ontario, CA. FDA records list 2 510(k) clearances between 2019-06-21 and 2020-03-24, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Flosonics Medical (R/A 1929803 ONTARIO Corp.) between 2019 and 2020. The busiest year on record is 2019, with 1. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Flosonics Medical (R/A 1929803 ONTARIO Corp.), by decision year
Year	Clearances
2019	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K200337	FloPatch (FP120)	DPW	Substantially Equivalent	2020-03-24
K191388	FloPatch (FP110)	DPW	Substantially Equivalent	2019-06-21

Registered establishments

FDA registered establishments for Flosonics Medical (R/A 1929803 ONTARIO Corp.), with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015139886	3015139886	FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)	325 Front St W, Toronto Ontario M5V 2Y1 CA	2026	DPW

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

DPWFlowmeter, Blood, Cardiovascular

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2517-2025	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.	Class III	2025-08-07	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain