Cleared Traditional

K890039 - KLEEN TEST BASIN SET

K890039 is an FDA 510(k) clearance for KLEEN TEST BASIN SET, manufactured by Kleen Test Products. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K890039 · Kleen Test Products · General Hospital
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Oct 1989
Decision
287d
Days
Class 2
Risk

K890039 is an FDA 510(k) clearance for the KLEEN TEST BASIN SET. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Kleen Test Products (Elkhorn, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 287 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 Kleen Test Products devices

FDA 510(k) Submission Details - K890039

510(k) Number K890039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date October 24, 1989
Days to Decision 287 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
158d slower than avg
Panel avg: 129d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
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 - JOL Catheter And Tip, Suction

All 49
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K890039.
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