Cleared Traditional

K926119 - EXEL HUBER INFUSION SET ROTATING WING

K926119 is an FDA 510(k) clearance for EXEL HUBER INFUSION SET ROTATING WING, manufactured by Exel Intl.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K926119 · Exel Intl. · General Hospital
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Aug 1993
Decision
251d
Days
Class 2
Risk

K926119 is an FDA 510(k) clearance for the EXEL HUBER INFUSION SET ROTATING WING. 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 August 11, 1993 after a review of 251 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 Exel Intl. devices

FDA 510(k) Submission Details - K926119

510(k) Number K926119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date August 11, 1993
Days to Decision 251 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
122d slower than avg
Panel avg: 129d · This submission: 251d
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 789
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K926119.
DURHAM
K930406 · Intl. Medical, Inc. · Sep 1993
DURHAM
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SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
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K925430 · Douglas Medical Products Corp. · Aug 1993
IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL
K925228 · Y · Jul 1993