Cleared Traditional

K890539 - SURE COUNT LIGHT HANDLE COVER

K890539 is an FDA 510(k) clearance for SURE COUNT LIGHT HANDLE COVER, manufactured by Kleen Test Products. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K890539 · Kleen Test Products · General & Plastic Surgery device
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Feb 1989
Decision
24d
Days
Class 2
Risk

K890539 is an FDA 510(k) clearance for the SURE COUNT LIGHT HANDLE COVER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Kleen Test Products (Elkhorn, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 - K890539

510(k) Number K890539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date February 27, 1989
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 - FTA Light, Surgical, Accessories

Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K890539.
KSEA SCB ACC CONTROL
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K993089 · Deroyal Cardiovascular, Inc. · Oct 1999
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K810292 · Medline Industries, Inc. · Mar 1981
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145
K780162 · Cavitron Corp. · Mar 1978