Cleared Traditional

K894695 - VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM

K894695 is an FDA 510(k) clearance for VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM, manufactured by Medistad Corp.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K894695 · Medistad Corp. · General Hospital
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Jan 1990
Decision
182d
Days
Class 2
Risk

K894695 is an FDA 510(k) clearance for the VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Medistad Corp. (North Wales, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 182 days - an extended review cycle.

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. Standard predicate reliance. 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 Medistad Corp. devices

FDA 510(k) Submission Details - K894695

510(k) Number K894695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date January 22, 1990
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 K894695.
YANKAUER SUCTION TUBE-RIGID TYPE
K896558 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
STOPCOCK
K896562 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TUBING CONNECTORS
K896563 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
MECONIUM ASPIRATOR
K893649 · Gish Biomedical, Inc. · Aug 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
SUCTION TUBES: HOUSE, BARON
K892549 · Zinnanti Surgical Instruments, Inc. · May 1989