Cleared Traditional

K821394 - SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER

K821394 is the FDA 510(k) clearance for SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER by Kleen Test Products. It is a Class 2 General Hospital device (product code MMK) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821394 · Kleen Test Products · General Hospital
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Jun 1982
Decision
23d
Days
Class 2
Risk

K821394 is an FDA 510(k) clearance for the SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER. 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 3, 1982 after a review of 23 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.

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Submission Details

510(k) Number K821394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 03, 1982
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
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.