Cleared Traditional

K041849 - TURBO-FLO PICC

K041849 is the FDA 510(k) clearance for TURBO-FLO PICC by Cook, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K041849 · Cook, Inc. · General Hospital
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Jul 2005
Decision
378d
Days
Class 2
Risk

K041849 is an FDA 510(k) clearance for the TURBO-FLO PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 21, 2005 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, Inc. devices

Submission Details

510(k) Number K041849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 08, 2004
Decision Date July 21, 2005
Days to Decision 378 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
249d slower than avg
Panel avg: 129d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 180
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K041849.
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
K051991 · C.R. Bard, Inc. · Oct 2005
VYGON NUTRILINE CATHETERS
K051690 · Vygon Corp. · Aug 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
K051194 · Becton, Dickinson & CO · Jul 2005
6 FR FL POWERHOHN AND POWERLINE CATHETER
K051417 · C.R. Bard, Inc. · Jun 2005
6 FR DL POWERPICC CATHETER
K050931 · C.R. Bard, Inc. · Jun 2005
POWERHOHN AND POWERLINE CATHETERS
K050185 · C.R. Bard, Inc. · May 2005