Cleared Traditional

K840443 - RETROGRADE INFUSION SET 3ML & 6ML-

K840443 is the FDA 510(k) clearance for RETROGRADE INFUSION SET 3ML & 6ML- by Tico Medical Instruments, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K840443 · Tico Medical Instruments, Inc. · General Hospital
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Apr 1984
Decision
76d
Days
Class 2
Risk

K840443 is an FDA 510(k) clearance for the RETROGRADE INFUSION SET 3ML & 6ML-. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Tico Medical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Tico Medical Instruments, Inc. devices

Submission Details

510(k) Number K840443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date April 17, 1984
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.

Regulatory Peers - FPA Set, Administration, Intravascular

All 471
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