510(k) Report

510(k) · Cleared

Cleared

Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen

K091586510(k) TraditionalCleared Jul 23, 200951-day reviewClass II21 CFR 880.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medcomp · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Jul 23, 2009 as substantially equivalent to K003682 (Medical Components, Inc., 2001) and 3 other predicates after a 51-day review. Its family tree reaches back 7 generations to 2000. 2 of the 30 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.

Decided
Jul 23, 2009
Review
51 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K001901 (2000). 20 ancestors in all, the oldest K830256 (1983). 9 later devices descend from it, 5 citing it directly. 2 of the 30 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2001: 3 other ancestors2004: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors, 1 with a Class I recall11999: 1 other ancestor1996: 1 other ancestor1983: 1 other ancestor1986: 1 other ancestor, 1 with a Class I recall12013: 4 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 7 other ancestors, 1 with a Class I recall14 generations back: 1 other ancestor, 1 with a Class I recall1 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 2 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 1 generation backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. This deviceK091586 Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp · 2009
  9. Descendant · cites it directly · 2 of its ownK123292 T3Medcomp · 2013
  10. Descendant · cites it directly · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
  11. Descendant · 2 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
  12. Descendant · cites it directly · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
  13. Descendant · cites it directly · 1 of its ownK123617 3F Pro-PiccMedical Components, Inc. · 2013

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012: 12013: 42014: 12019: 12020: 12023: 1
2012high 4 (2013) · low 0 (2015)2026

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip4 generations back · 1986

Most influential descendants

Showing 5 of 9 · See all
  • K123292T3Medcomp · 2013 · cites it directly2descendants
  • K130034Uni-PiccHealth Line International Corporation · 2013 · cites it directly2descendants
  • K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 2 generations on1descendant
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · cites it directly1descendant
  • K1236173F Pro-PiccMedical Components, Inc. · 2013 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−3K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−2K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−1K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
0 (this device)K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp2009—
+1K123292T3Medcomp2013—
+1K130034Uni-PiccHealth Line International Corporation2013—
+2K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)2019—
+1K140270Nexus Midline CT CatheterHealth Line International Corporation2014—
+1K1236173F Pro-PiccMedical Components, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199610
199910
200021
200130
200310
200410
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201340
201410
201910
202010
202310
FIG. 1 — Lineage of K091586, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LJS device

  1. #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003682Medcomp Z-Cath
Summary page 1
…on Name: Long Term Intravascular Catheter (80 LJS) C.F.R. Section: 880.5970 Class: II C. Predicate Devices: K003682 Medcomp, Z-Cath PICC K001901 Bard Access, Poly-Q-Cath® Midline…
Medical Components, Inc.20012
*K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model…
Summary page 1
…C.F.R. Section: 880.5970 Class: II C. Predicate Devices: K003682 Medcomp, Z-Cath PICC K001901 Bard Access, Poly-Q-Cath® Midline K043502 Bard Access, Poly Per-Q-Cath®…
C.R. Bard, Inc.20002
*K0435026 FR Poly Per-Q-Cath Triple Lumen Picc
Summary page 1
…C. Predicate Devices: K003682 Medcomp, Z-Cath PICC K001901 Bard Access, Poly-Q-Cath® Midline K043502 Bard Access, Poly Per-Q-Cath® Triple Lumen PICC Catheter…
C.R. Bard, Inc.2005—
*K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line
Summary page 1
…K043502 Bard Access, Poly Per-Q-Cath® Triple Lumen PICC Catheter K051991 Bard Access, Poly-Q-Cath PICC D. Device Description: The Vascu-PICC® and Midline Catheters are designed for peripheral v…
C.R. Bard, Inc.2005—

Also cleared against K003682: 2 other devices →

What descends from it? (9)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123292T3Medcomp20132
K130034Uni-PiccHealth Line International Corporation20132
K140270Nexus Midline CT CatheterHealth Line International Corporation20141
K1236173F Pro-PiccMedical Components, Inc.20131
K122423Vasu-PiccMedical Components, Inc.20120

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
  • K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 10 of the 20 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K123292 (Medcomp, 2013) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K003682.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LJS

8in 2025

2007: 142008: 42009: 162010: 92011: 62012: 142013: 142014: 82015: 72016: 92017: 72018: 102020: 22021: 32022: 32023: 42024: 12025: 82026 (partial year): 2
2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007: 92 days median2008: 97 days median2009: 70 days median2010: 114 days median2011: 55 days median2012: 77 days median2013: 31 days median2014: 47 days median2015: 71 days median2016: 128 days median2017: 101 days median2018: 148 days median2021: 284 days median2022: 177 days median2023: 47 days median2025: 171 days median
2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2008: 12009: 12010: 122011: 42012: 402014: 152015: 22016: 182017: 92018: 32021: 12023: 5, 2 Class I2026 (partial year): 8, 1 Class I
2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007: 3922008: 3692009: 3792010: 4952011: 6962012: 5642013: 6802014: 8422015: 1,3062016: 1,1232017: 2,1002018: 2,3242019: 2,0522020: 2,5392021: 3,0842022: 3,2562023: 2,7992024: 4,2432025: 4,372
2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714920392
20084971369
200916701379
2010911412495
20116554696
2012147740564
201314310680
201484715842
201577121,306
20169128181,123
2017710192,100
20181014832,324
20190—02,052
20202—02,539
2021328413,084
2022317703,256
20234475 (2)2,799
20241—04,243
2025817104,372
20262—8 (1)—

What is it indicated for?

The Peripherally Inserted Central Vein Access catheters are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used.

The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (See Contraindications). For blood therapy it is recommended that a 4French or larger catheter be used.

Indications for use as stated in the FDA summary.

Also cleared against K003682

2 other devices cite the same predicate.

  • K122423Vasu-PiccMedical Components, Inc. · 2012
  • K063363Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007

More from Medcomp

40 FDA decisions under this applicant name. See the company

  • K130889Split Cath RGMedcomp · 2014
  • K123292T3Medcomp · 2013
  • K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
  • K091954Micro-Stick SetMedcomp · 2010
  • K091953Pro-PiccMedcomp · 2009

Recent decisions in LJS

The LJS category page

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025

https://510kreport.com/device/K091586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091586

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026