Cleared Traditional

K893135 - GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

K893135 is an FDA 510(k) clearance for GENT-L-KARE STER SUCT CATH TRAY W/14 FR..., manufactured by Premium Plastics, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K893135 · Premium Plastics, Inc. · General Hospital
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Jun 1989
Decision
58d
Days
Class 2
Risk

K893135 is an FDA 510(k) clearance for the GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Premium Plastics, Inc. (Elkhorn, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 58 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 Premium Plastics, Inc. devices

FDA 510(k) Submission Details - K893135

510(k) Number K893135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date June 22, 1989
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 52
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K893135.
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