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Biodrain Streamway Fluid Management System

by Biodrain Medical, Inc.

510(k) K090759

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090759 Date1 Apr 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JCX
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Biodrain Streamway Fluid Management System is an apparatus for suction, designed for ward use and portable operation. It is an AC-powered device that manages fluid collection and evacuation in clinical settings.

The system is supplied by Biodrain Medical, Inc. and is classified as a Class II medical device. It has received FDA 510(k) clearance with the K number K090759 and is intended for use in general and plastic surgery procedures. The device is not specified as single-use or reusable, and no MRI safety information is provided.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Biodrain Streamway Fluid Management System used for?

    The Biodrain Streamway Fluid Management System is an apparatus for suction designed for ward use and portable operation. It manages fluid collection and evacuation in clinical settings, specifically intended for use in general and plastic surgery procedures.

  • Is the Biodrain Streamway Fluid Management System single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. This suggests it may be designed for multiple uses, but specific reprocessing instructions would need to be obtained from the manufacturer.

  • What regulatory approvals does the Biodrain Streamway Fluid Management System have?

    The Biodrain Streamway Fluid Management System has received FDA 510(k) clearance with the K number K090759. It is classified as a Class II medical device and is cleared for use in general and plastic surgery procedures.

  • How is the Biodrain Streamway Fluid Management System supplied?

    The system is supplied by Biodrain Medical, Inc. and is an AC-powered device designed for ward use and portable operation. The device manages fluid collection and evacuation in clinical settings.