Cleared Traditional

NON-STERILE CATHETER REPAIR KITS (K830406) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830406 · Evermed, Inc. · Microbiology device
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Mar 1983
Decision
22d
Days
Class 2
Risk

K830406 is an FDA 510(k) clearance for the NON-STERILE CATHETER REPAIR KITS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Evermed, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 880.5970 - the FDA microbiology 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 Evermed, Inc. devices

Submission Details

510(k) Number K830406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date March 01, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 Microbiology devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 79
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K830406.
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K851243 · Cook, Inc. · Mar 1986
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K843450 · Sherwood Medical Co. · Nov 1984