Cleared Traditional

K091586 - VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN

K091586 is an FDA 510(k) clearance for VASCU-PICC AND MIDLINE CATHETERS, manufactured by Medcomp. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K091586 · Medcomp · General Hospital
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Jul 2009
Decision
51d
Days
Class 2
Risk

K091586 is an FDA 510(k) clearance for the VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on July 23, 2009 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medcomp devices

FDA 510(k) Submission Details - K091586

510(k) Number K091586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date July 23, 2009
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 216
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K091586.
PRO-PICC
K091953 · Medcomp · Sep 2009
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K092347 · Medcomp · Sep 2009
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
K091324 · C.R. Bard, Inc. · Aug 2009
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670 · Becton, Dickinson & CO · Jul 2009
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466 · Medcomp · Jun 2009
NMI PICC
K091261 · Navilyst Medical, Inc. · May 2009