Cleared Traditional

K896134 - ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.

K896134 is an FDA 510(k) clearance for ACUFLO, manufactured by Goosen Enterprises, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K896134 · Goosen Enterprises, Inc. · General Hospital
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Aug 1990
Decision
310d
Days
Class 2
Risk

K896134 is an FDA 510(k) clearance for the ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Goosen Enterprises, Inc. (Goldenrod, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Goosen Enterprises, Inc. devices

FDA 510(k) Submission Details - K896134

510(k) Number K896134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date August 30, 1990
Days to Decision 310 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 129d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 58
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K896134.
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THORA-KLEX CHEST DRAINAGE UNIT
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CODMAN SUCTION PATTIE
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MANIFOLD
K896804 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
UNIVERSAL POOLE SUCTION TUBE
K896556 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990