Cleared Traditional

WILTEK IRRIGAITON/ASPIRATION TUBE SET (K922989) - FDA 510(k) Clearance

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

K922989 · Wiltek Medical, Inc. · General Hospital
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Feb 1994
Decision
603d
Days
Class 2
Risk

K922989 is an FDA 510(k) clearance for the WILTEK IRRIGAITON/ASPIRATION TUBE SET. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 603 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Wiltek Medical, Inc. devices

Submission Details

510(k) Number K922989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date February 15, 1994
Days to Decision 603 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
474d slower than avg
Panel avg: 129d · This submission: 603d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYY Tube, Aspirating, Flexible, Connecting
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.