510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013803Substantially Equivalent

Flowguard Device

Biosonix, Ltd., Kfar Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013803 is the FDA 510(k) clearance record for FLOWGUARD DEVICE, a class II device, cleared for Biosonix , Ltd. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list one 510(k) clearance for Biosonix , Ltd. As of , FDA records show no recalls naming K013803.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosonix , Ltd. Beit Hapa'Amon (Box 124), Kfar Saba, IL
510(k) summary
Summary
Third party review
No

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260