Cleared Traditional

K890098 - KLEEN TEST O.R. KIT

K890098 is an FDA 510(k) clearance for KLEEN TEST O.R. KIT, manufactured by Kleen Test Products. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K890098 · Kleen Test Products · General & Plastic Surgery device
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Jan 1989
Decision
14d
Days
Class 2
Risk

K890098 is an FDA 510(k) clearance for the KLEEN TEST O.R. KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Kleen Test Products (Elkhorn, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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 Kleen Test Products devices

FDA 510(k) Submission Details - K890098

510(k) Number K890098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date January 24, 1989
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 60
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K890098.
SUTURE REMOVAL KIT
K890729 · Cypress Medical Products, Ltd. · Apr 1989
TRACHEOSTOMY CARE AND CLEANING KITS
K890726 · Cypress Medical Products, Ltd. · Mar 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · North American Instrument Corp. · Feb 1989
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · Standard Textile Co., Inc. · Aug 1988
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
SOFT TISSUE ANCHORING SET KIT
K874439 · Concept, Inc. · Nov 1987