Cleared Traditional

EDRAIN CHEST DRAINAGE SYSTEM (K130131) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130131 · Atrium Medical Corp. · General & Plastic Surgery device
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Feb 2013
Decision
41d
Days
Class 2
Risk

K130131 is an FDA 510(k) clearance for the EDRAIN CHEST DRAINAGE SYSTEM. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 41 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.

View all Atrium Medical Corp. devices

Submission Details

510(k) Number K130131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2013
Decision Date February 28, 2013
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or 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 Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 33
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K130131.
SOMAVAC Device
K180606 · Somavac Medical Solutions, Inc. · May 2018
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Aprima Smartesis Centesis Pump
K161002 · Cook Incorporated · Sep 2016
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · Stryker Corp. · Sep 1979