510(k) Report

510(k) · Cleared

Cleared

Powergroshong Picc Catheter

K063848510(k) TraditionalCleared Apr 4, 200797-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

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

Cleared on Apr 4, 2007 as substantially equivalent to K023374 (C.R. Bard, Inc., 2002) and 1 other predicate after a 97-day review. Its family tree reaches back 7 generations to 2000. 1 of the 19 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Apr 4, 2007
Review
97 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K001901 (2000). 12 ancestors in all, the oldest K904558 (1991). 6 later devices descend from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2005: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor2004: 1 other ancestor2007: 1 descendant cleared2016: 1 descendant cleared2021: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2013: 1 descendant cleared2018: 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. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005×2: 2 generations cleared close together, K051672 (2005), K053501 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants, 1 with a Class I recall13 generations forward: 1 descendant K053501 · Powerpicc · Bard Access Systems, Inc. · 2006K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · 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 backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK053501 PowerpiccBard Access Systems, Inc. · 2006
  8. This deviceK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
  9. Descendant · cites it directly · 5 of its ownK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK151985 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016
  11. Descendant · 2 generations on · 0 of its ownK210264 BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · Recalled (Class I)
  12. Descendant · 3 generations on · 0 of its ownK181904 5 FR Dual Lumen Piper PICCPiper Access, LLC · 2018
  13. Descendant · 2 generations on · 0 of its ownK141633 Pro-Picc with Valve TechnologyMedical Components, Inc. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12013: 12014: 12016: 12018: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

Class I recalls in this family

  • K210264 BD PowerPiCC Catheter2 generations on · 2021

Most influential descendants

Showing 5 of 6 · See all
  • K072230Powerpicc SoloC.R. Bard, Inc. · 2007 · cites it directly5descendants
  • K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc. · 2016 · 2 generations on1descendant
  • K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 2 generations on0descendants
  • K1819045 FR Dual Lumen Piper PICCPiper Access, LLC · 2018 · 3 generations on0descendants
  • K141633Pro-Picc with Valve TechnologyMedical Components, Inc. · 2014 · 2 generations on0descendants
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—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K053501PowerpiccBard Access Systems, Inc.2006—
0 (this device)K063848Powergroshong Picc CatheterC.R. Bard, Inc.2007—
+1K072230Powerpicc SoloC.R. Bard, Inc.20074
+2K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.2016—
+2K210264BD PowerPiCC CatheterBard Access Systems, Inc.2021Class I
+3K1819045 FR Dual Lumen Piper PICCPiper Access, LLC2018—
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
200210
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201310
201410
201610
201810
202111
FIG. 1 — Lineage of K063848, 2000–2021Source: 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.

1 device in this family has 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? (2)

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
*K023374Groshong NXT Dual Lumen Picc Catheters
Summary page 1
…21 CFR 880.5970- Class 11 Classification Panel: General Hospital 5 Fr DL Groshong® nXt PICC Catheter 1K023374 12/18/2002 6 Fr TL PowerPICC® Catheter 1K053501 1/13/2006 5.4 Intend…
C.R. Bard, Inc.20025
*K053501Powerpicc
Summary page 1
…spital 5 Fr DL Groshong® nXt PICC Catheter 1K023374 12/18/2002 6 Fr TL PowerPICC® Catheter 1K053501 1/13/2006 5.4 Intended Use The intended use of the 5 Fr SL PowerGroshong is the same as the intended use of…
Bard Access Systems, Inc.2006—

Also cleared against K023374: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072230Powerpicc SoloC.R. Bard, Inc.20075

Has anything in its family been recalled? (1 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.

  • K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 6 of the 12 ancestors have a recall of any class.
  • Of its descendants, K072230 (C.R. Bard, Inc., 2007) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K023374.

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. 2007, 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 PowerGroshongTM PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Indications for use as stated in the FDA summary.

Also cleared against K023374

2 other devices cite the same predicate.

  • K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
  • K034020Groshong NXT Picc CathetersC.R. Bard, Inc. · 20044 recalls

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/K063848 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063848: Powergroshong Picc Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063848

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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