Cleared Traditional

K896558 - YANKAUER SUCTION TUBE-RIGID TYPE

K896558 is an FDA 510(k) clearance for YANKAUER SUCTION TUBE-RIGID TYPE, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K896558 · Westmark, Sterile Packing Systems, Inc. (Sps) · General Hospital
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Feb 1990
Decision
81d
Days
Class 2
Risk

K896558 is an FDA 510(k) clearance for the YANKAUER SUCTION TUBE-RIGID TYPE. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 6, 1990 after a review of 81 days - a notably fast clearance 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: 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896558

510(k) Number K896558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date February 06, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
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 53
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K896558.
MANIFOLD
K896804 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
UNIVERSAL POOLE SUCTION TUBE
K896556 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
YANKAUER SUCTION TUBE-FLEXIBLE TYPE
K896557 · 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