Cleared Traditional

K090759 - BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM

K090759 is an FDA 510(k) clearance for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM, manufactured by Biodrain Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K090759 · Biodrain Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
9d
Days
Class 2
Risk

K090759 is an FDA 510(k) clearance for the BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Biodrain Medical, Inc. (Mendota Heights, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K090759

510(k) Number K090759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date April 01, 2009
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 68
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K090759.
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AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
K082762 · Aardvark Medical · Nov 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · Cardinalhealth · Apr 2008
TRANSPOSAL ULTRA SYSTEMS
K081047 · Dornoch Medical Systems, Inc. · Apr 2008

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K090759 · BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
Download PDF FDA Summary Biodrain Medical, Inc.