Cleared Special

K141818 - TURBO-JECT PICC SETS

K141818 is an FDA 510(k) clearance for TURBO-JECT PICC SETS, manufactured by Cook Corporated. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 29-day FDA review.

K141818 · Cook Corporated · General Hospital
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Aug 2014
Decision
29d
Days
Class 2
Risk

K141818 is an FDA 510(k) clearance for the TURBO-JECT PICC SETS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cook Corporated (Bloomington, US). The FDA issued a Cleared decision on August 5, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Corporated devices

FDA 510(k) Submission Details - K141818

510(k) Number K141818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date August 05, 2014
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 209
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K141818.
Sherlock 3CG Tip Positioning System Stylet
K142267 · C.R. Bard, Inc. · Oct 2014
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PRO-PICC WITH VALVE TECHNOLOGY
K141633 · Medical Components, Inc. · Sep 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345 · C.R. Bard, Inc. · Mar 2014
NMI PICC IV
K140266 · Navilyst Medical, Inc. · Mar 2014
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · Cook, Inc. · Dec 2013