Cleared Traditional

K963659 - EXEL I.V. ADMINISTRATION SET

K963659 is the FDA 510(k) clearance for EXEL I.V. ADMINISTRATION SET by Exel Intl.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K963659 · Exel Intl. · General Hospital
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Dec 1997
Decision
469d
Days
Class 2
Risk

K963659 is an FDA 510(k) clearance for the EXEL I.V. ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Exel Intl. (Culver City, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Exel Intl. devices

Submission Details

510(k) Number K963659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date December 16, 1997
Days to Decision 469 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 129d · This submission: 469d
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 465
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K963659.
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