Cleared Traditional

K001106 - MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000

K001106 is an FDA 510(k) clearance for MASTERSITE NEEDLELESS LUER ACTIVATED IV..., manufactured by Creative Plastic Technology. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K001106 · Creative Plastic Technology · General Hospital
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Aug 2000
Decision
133d
Days
Class 2
Risk

K001106 is an FDA 510(k) clearance for the MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Creative Plastic Technology (Dana Point, US). The FDA issued a Cleared decision on August 16, 2000 after a review of 133 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 Creative Plastic Technology devices

FDA 510(k) Submission Details - K001106

510(k) Number K001106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2000
Decision Date August 16, 2000
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K001106.
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · Sterling Medivations, Inc. · Dec 2000
SIMPLICITY SOFT INFUSION SET
K002492 · Sterling Medivations, Inc. · Oct 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
SURGEN VALVE
K990331 · Tiva Medical · May 2000
POSI-LINK
K000472 · Icu Medical, Inc. · May 2000