Cleared Traditional

K943897 - NU-SITE

K943897 is an FDA 510(k) clearance for NU-SITE, manufactured by Medex, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K943897 · Medex, Inc. · General Hospital
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Feb 1995
Decision
184d
Days
Class 2
Risk

K943897 is an FDA 510(k) clearance for the NU-SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 184 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medex, Inc. devices

FDA 510(k) Submission Details - K943897

510(k) Number K943897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1994
Decision Date February 10, 1995
Days to Decision 184 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 129d · This submission: 184d
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 773
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