Cleared Traditional

K011405 - EXEL INJECTION PLUG WITH CAP

K011405 is an FDA 510(k) clearance for EXEL INJECTION PLUG WITH CAP, manufactured by Exelint Intl. Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K011405 · Exelint Intl. Co. · General Hospital
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Sep 2001
Decision
142d
Days
Class 2
Risk

K011405 is an FDA 510(k) clearance for the EXEL INJECTION PLUG WITH CAP. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Exelint Intl. Co. (Los Angeles, US). The FDA issued a Cleared decision on September 27, 2001 after a review of 142 days - within the typical 510(k) review window.

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 Exelint Intl. Co. devices

FDA 510(k) Submission Details - K011405

510(k) Number K011405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date September 27, 2001
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
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 513
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K011405.
SIMPLICITY CLASSIC WING QD INFUSION SET
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SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
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SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
K013104 · Sterling Medivations, Inc. · Oct 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · Sterling Medivations, Inc. · Sep 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SIMPLICITY EURO QD INFUSION SET
K012330 · Sterling Medivations, Inc. · Aug 2001