Chrysalis Intelligence · Sponsors · Flosonics Medical (R/A 1929803 Ontario Corp.)

Flosonics Medical (R/A 1929803 Ontario Corp.)

Toronto, CA · 1 510(k) clearances · 1 recalls

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Total clearances
1
2020-03-24 → 2020-03-24
Last 12 months
0
Product codes
1
Most recent
2020-03-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DPW Flowmeter, Blood, Cardiovascular Class II Cardiovascular 1 2020-03-24
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-08-07
DateSeverityStatusRecall # ProductCodeReason
2025-08-07 Class III Ongoing 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.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-03-24 K200337 FloPatch (FP120) DPW Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence