Cleared Traditional

K161496 - Turbo-Flo PICC Sets

K161496 is an FDA 510(k) clearance for Turbo-Flo PICC Sets, manufactured by Cook Incorporated. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K161496 · Cook Incorporated · General Hospital
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Oct 2016
Decision
128d
Days
Class 2
Risk

K161496 is an FDA 510(k) clearance for the Turbo-Flo PICC Sets. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 7, 2016 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Cook Incorporated devices

FDA 510(k) Submission Details - K161496

510(k) Number K161496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date October 07, 2016
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 208
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K161496.
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · C.R. Bard, Inc. · Apr 2017
PICC Maximal Barrier Nursing Kit
K163452 · Navilyst Medical, Inc. · Feb 2017
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985 · C.R. Bard, Inc. · Jun 2016
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · Navilyst Medical, Inc. · Sep 2015
Xcela Power Injectable PICC
K150527 · Navilyst Medical, Inc. · Mar 2015