510(k) Report

510(k) · Cleared

Cleared

V-Cath Poly Picc

K071875510(k) TraditionalCleared Nov 5, 2007122-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

Hdc Corp. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Nov 5, 2007 as substantially equivalent to K033853 (Hdc Corp., 2004) and 3 other predicates after a 122-day review. Its family tree reaches back 8 generations to 2000. 2 of the 33 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.

Decided
Nov 5, 2007
Review
122 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K001901 (2000). 23 ancestors in all, the oldest K830256 (1983). 9 later devices descend from it, 2 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 4 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 recall12011: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2020: 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) K062579 · Omnipicc P.I. · Rita Medical Systems, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 7 other ancestors, 1 with a Class I recall15 generations back: 1 other ancestor, 1 with a Class I recall1 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 2 descendants K062579 · Omnipicc P.I. · Rita Medical Systems, Inc. · 2006K051991 · 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 backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
  9. This deviceK071875 V-Cath Poly PiccHdc Corp. · 2007
  10. Descendant · cites it directly · 8 of its ownK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
  11. Descendant · 2 generations on · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
  12. Descendant · 3 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
  13. Descendant · 3 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
  14. Descendant · 3 generations on · 1 of its ownK113622 Orion II CT CVCHealth Line International Corporation (Hlic) · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 22013: 12014: 12019: 12020: 1
2009high 2 (2012) · low 0 (2015)2026

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…4 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip5 generations back · 1986

Most influential descendants

Showing 5 of 9 · See all
  • K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · cites it directly8descendants
  • K101329Synergy CT PiccHealth Line International Corporation · 2010 · 2 generations on6descendants
  • K130034Uni-PiccHealth Line International Corporation · 2013 · 3 generations on2descendants
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 3 generations on1descendant
  • K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012 · 3 generations on1descendant
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—
−1K062579Omnipicc P.I.Rita Medical Systems, Inc.2006—
0 (this device)K071875V-Cath Poly PiccHdc Corp.2007—
+1K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.20093
+2K101329Synergy CT PiccHealth Line International Corporation2010—
+3K130034Uni-PiccHealth Line International Corporation2013—
+3K140270Nexus Midline CT CatheterHealth Line International Corporation2014—
+3K113622Orion II CT CVCHealth Line International Corporation (Hlic)2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199610
199910
200021
200120
200310
200420
200540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201220
201310
201410
201910
202010
FIG. 1 — Lineage of K071875, 2000–2020Source: 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
*K033853Modification to V-Cath Poly Picc
Summary page 1
…Number: 880.5970 D. Panel: General Hospital E. Product Code: LJS F. Class: Class II Predicate Devices V-Cath Poly PICC from HDC Corporation, K033853 OMNIPICC P.I. from RITA Medical Systems, Inc., K051102 OMNIPICC P.1. from RITA Medical Systems, Inc., K062579…
Hdc Corp.2004—
*K051102Omnipicc PI
Summary page 1
…Product Code: LJS F. Class: Class II Predicate Devices V-Cath Poly PICC from HDC Corporation, K033853 OMNIPICC P.I. from RITA Medical Systems, Inc., K051102 OMNIPICC P.1. from RITA Medical Systems, Inc., K062579 PowerPICC Catheter, Bard Access Systems, Inc., K033389 Devic…
Rita Medical Systems, Inc.2005—
*K062579Omnipicc P.I.
Summary page 1
…V-Cath Poly PICC from HDC Corporation, K033853 OMNIPICC P.I. from RITA Medical Systems, Inc., K051102 OMNIPICC P.1. from RITA Medical Systems, Inc., K062579 PowerPICC Catheter, Bard Access Systems, Inc., K033389 Device Description The Power-V PICC is a family of peripherally ins…
Rita Medical Systems, Inc.2006—
*K033389Powerpicc Catheters, Models 3175155, 3175135
Summary page 1
…MNIPICC P.I. from RITA Medical Systems, Inc., K051102 OMNIPICC P.1. from RITA Medical Systems, Inc., K062579 PowerPICC Catheter, Bard Access Systems, Inc., K033389 Device Description The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast…
C.R. Bard, Inc.20041

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.20098
K110914Triple Lumen PFM PiccPfm Medical, Inc.20110

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 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 10 of the 23 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K083873 (Pfm Medical, Inc., 2009) has gone furthest, with 8 descendants of its own.

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 Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.

Indications for use as stated in the FDA summary.

More from Hdc Corp.

30 FDA decisions under this applicant name. See the company

  • K023342Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping Probe, Neuro-Trace…Hdc Corp. · 2004
  • K033853Modification to V-Cath Poly PiccHdc Corp. · 2004
  • K032404Seldinger Safety Needle IntroducerHdc Corp. · 2003
  • K022752Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 &…Hdc Corp. · 2003
  • K022099Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp. · 2002

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/K071875 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071875: V-Cath Poly Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071875

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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