Cleared Traditional

K801259 - NEEDLE COUNTER-SURE COUNT/100 COUNT

K801259 is the FDA 510(k) clearance for NEEDLE COUNTER-SURE COUNT/100 COUNT by Kleen Test Products. It is a Class 2 General Hospital device (product code MMK) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K801259 · Kleen Test Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
12d
Days
Class 2
Risk

K801259 is an FDA 510(k) clearance for the NEEDLE COUNTER-SURE COUNT/100 COUNT. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Kleen Test Products (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Kleen Test Products devices

Submission Details

510(k) Number K801259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 09, 1980
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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.