Cleared Traditional

K841859 - SECURA SET

K841859 is an FDA 510(k) clearance for SECURA SET, manufactured by Diatek, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K841859 · Diatek, Inc. · General Hospital
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Jul 1984
Decision
60d
Days
Class 2
Risk

K841859 is an FDA 510(k) clearance for the SECURA SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Diatek, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1984 after a review of 60 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.

FDA 510(k) Submission Details - K841859

510(k) Number K841859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1984
Decision Date July 03, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 1141
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K841859.
HESUNG'S SOLUTION INFUSION SETS
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THREE WAY INFUSION SET
K841882 · Med Fusion Systems, Inc. · Jun 1984
PLASTIC, STERILE TUBING CLOSED SET
K841185 · Marbex, Inc. · May 1984
INFUSION SET SCALP VEIN
K841186 · Marbex, Inc. · May 1984
K841859 · SECURA SET
Download PDF Diatek, Inc.