Cleared Traditional

K896134 - ACUFLO

K896134 is the FDA 510(k) clearance for ACUFLO by Goosen Enterprises, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 40
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K896134.
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337 · Deknatel, Inc. · Jul 1993
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377 · CooperSurgical, Inc. · Apr 1991
THORA-KLEX CHEST DRAINAGE UNIT
K905448 · Davol, Inc. · Mar 1991
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
MECONIUM ASPIRATOR
K893649 · Gish Biomedical, Inc. · Aug 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989