510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Powerpicc SV Catheters

K102159510(k) TraditionalCleared Nov 17, 2010107-day reviewClass II21 CFR 880.5970Recalls 3

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

C.R. Bard, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Nov 17, 2010 as substantially equivalent to K034019 (C.R. Bard, Inc., 2004) and 7 other predicates after a 107-day review. Its family tree reaches back 8 generations to 2000. 2 of the 34 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times.

Decided
Nov 17, 2010
Review
107 days
Class
Class II
Product code
LJS
Recalls
3
Predicates
8

Its longest line of descent runs back 8 generations to K001901 (2000). 28 ancestors in all, the oldest K830256 (1983). 5 later devices descend from it, 2 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2007: 3 other ancestors2006: 2 other ancestors2005: 3 other ancestors2004: 2 other ancestors2003: 1 other ancestor2001: 2 other ancestors2000: 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 recall12016: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2017: 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) K070996 · 4 FR Single Lumen (SL) Powerpicc Catheter · C.R. Bard, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 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: 2 descendants2 generations forward: 3 descendants K070996 · 4 FR Single Lumen (SL) Powerpicc Catheter · C.R. Bard, Inc. · 2007K051991 · 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 · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 1 generation backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  9. This deviceK102159 Powerpicc SV CathetersC.R. Bard, Inc. · 2010
  10. Descendant · cites it directly · 2 of its ownK162443 PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · Recalled
  11. Descendant · 2 generations on · 1 of its ownK162441 PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017
  12. Descendant · cites it directly · 1 of its ownK123617 3F Pro-PiccMedical Components, Inc. · 2013
  13. Descendant · 2 generations on · 0 of its ownK180548 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018 · Recalled
  14. Descendant · 2 generations on · 0 of its ownK131687 6F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc. · 2013

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 5 · See all
  • K162443PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · cites it directly2descendants
  • K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017 · 2 generations on1descendant
  • K1236173F Pro-PiccMedical Components, Inc. · 2013 · cites it directly1descendant
  • K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018 · 2 generations on0descendants
  • K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−7K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−6K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−5K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−4K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−3K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−2K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−1K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.2007—
0 (this device)K102159Powerpicc SV CathetersC.R. Bard, Inc.2010—
+1K162443PowerPICC Provena CathetersC.R. Bard, Inc.20161
+2K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.2017—
+1K1236173F Pro-PiccMedical Components, Inc.2013—
+2K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen…C.R. Bard, Inc (Bard Has Joined Bd)20181
+2K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199610
199910
200021
200120
200310
200420
200530
200620
200730
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201610
201710
201810
FIG. 1 — Lineage of K102159, 2000–2018Source: 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? (8)

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
*K034019Poly Per-Q-Cath Picc Catheters
Summary page 1
…catheter, LJS, 21 CFR §880.5970 Class 11 Premnarket Notification: K034019, KO5i1991 Manufacturer. Bard Access Systems, Inc. Trade Name:…
C.R. Bard, Inc.20041
*K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line
Summary page 1
…catheter, LJS, 21 CFR §880.5970 Class 1I Premarket Notification: K033389, K051991 Manufacturer: Bard Access Systems, Inc Trade Name:…
C.R. Bard, Inc.2005—
*K0435026 FR Poly Per-Q-Cath Triple Lumen Picc
Summary page 1
…catheter, LJS, 21 CFR §880.5970 Class 11 Premarket Notification: K043502, KO5i1991 Manufacturer: Bard Access Systems, Inc. Predicate Devices Trade Name:…
C.R. Bard, Inc.2005—
*K0709964 FR Single Lumen (SL) Powerpicc Catheter
Summary page 1
…catheter, UJS, 21 CFR §880.5970 Class II Premarket Notification: K070996 Manufacturer: Bard Access Systems, Inc Trade Name: SF Si…
C.R. Bard, Inc.2007—
*K033389Powerpicc Catheters, Models 3175155, 3175135
Summary page 1
…catheter, LJS, 21 CFR §880.5970 Class 1I Premarket Notification: K033389, K051991 Manufacturer: Bard Access Systems, Inc Trade Name:…
C.R. Bard, Inc.20041
*K053501Powerpicc
Summary page 2
…catheter, LJS, 21 CFR §880.5970 Class II Premarket Notification: K053501, K051991 Manufacturer: Bard Access Systems, Inc Trade Name: Powerl…
Bard Access Systems, Inc.2006—
*K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…
Summary page 2
…catheter, UJS, 21 CIFR §880.5970 Class 1I Premarket Notification: K093927 Manufacturer: Bard Access Systems, Inc Trade Name: Morpheuso CT PI…
C.R. Bard, Inc.2010—
*K072196Angiodynamics, Inc Morpheus Picc and Procedure Kit
Summary page 2
…catheter, LJS, 21 CIFR §880.5970 Class 11 Premarket Notification: K0721 96 Manufacturer: Angiooynamics, Inc The subject PowerPlCC" SV catheters are member…
AngioDynamics, Inc.2007—

Also cleared against K034019: 5 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K162443PowerPICC Provena CathetersC.R. Bard, Inc.20162
K1236173F Pro-PiccMedical Components, Inc.20131

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

Recalls of this device

DateClassRecallRoot causeReason
May 21, 2026Class IIZ-2659-2026Nonconforming Material/ComponentDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Feb 26, 2020Class IIZ-2080-2020Under Investigation by firmThe kits contain surgical gowns which were subject to a recall by the supplier.
Feb 26, 2020Class IIZ-2081-2020Under Investigation by firmThe kits contain surgical gowns which were subject to a recall by the supplier.

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 10 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
  • 10 of the 28 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K162443 (C.R. Bard, Inc., 2016) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate K034019.

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. 2010, 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 PowerPICC SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate

3 F Single Lumen 1 mL/sec

4 F Dual Lumen 2.5 mL/sec

Indications for use as stated in the FDA summary.

Also cleared against K034019

5 other devices cite the same predicate.

  • K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
  • K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005
  • K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 20051 recall
  • K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  • K0435026 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc. · 2005

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K102159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102159: Powerpicc SV Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102159

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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