510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K090759Substantially Equivalent

Biodrain Streamway Fluid Management System

Biodrain Medical, Inc., Mendota Heights MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090759 is the FDA 510(k) clearance record for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM, a class II device, cleared for Biodrain Medical, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list one 510(k) clearance for Biodrain Medical, Inc. As of , FDA records show no recalls naming K090759.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biodrain Medical, Inc. 2060 Centre Pt.e Blvd., Mendota Heights MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JCX

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