510(k) Report

510(k) · Cleared

Cleared

Omnipicc P.I.

K062579510(k) TraditionalCleared Nov 28, 200689-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

Rita Medical Systems, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Nov 28, 2006 as substantially equivalent to K051102 (Rita Medical Systems, Inc., 2005) and 4 other predicates after an 89-day review. Its family tree reaches back 7 generations to 2000. 2 of the 32 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided
Nov 28, 2006
Review
89 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
5

Its longest line of descent runs back 7 generations to K001901 (2000). 21 ancestors in all, the oldest K830256 (1983). 10 later devices descend from it, 2 citing it directly. 2 of the 32 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 4 other ancestors2004: 1 other ancestor2003: 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 recall12010: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2009: 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 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: 2 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants 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 deviceK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
  9. Descendant · cites it directly · 9 of its ownK071875 V-Cath Poly PiccHdc Corp. · 2007
  10. Descendant · 2 generations on · 8 of its ownK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
  11. Descendant · cites it directly · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
  12. Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
  13. Descendant · 2 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12011: 12012: 22013: 12014: 12019: 12020: 1
2007high 2 (2012) · low 0 (2008)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 10 · See all
  • K071875V-Cath Poly PiccHdc Corp. · 2007 · cites it directly9descendants
  • K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · 2 generations on8descendants
  • K101329Synergy CT PiccHealth Line International Corporation · 2010 · cites it directly6descendants
  • K130034Uni-PiccHealth Line International Corporation · 2013 · 2 generations on2descendants
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
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)K062579Omnipicc P.I.Rita Medical Systems, Inc.2006—
+1K071875V-Cath Poly PiccHdc Corp.2007—
+2K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.20093
+1K101329Synergy CT PiccHealth Line International Corporation2010—
+2K130034Uni-PiccHealth Line International Corporation2013—
+2K140270Nexus Midline CT CatheterHealth Line International Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199610
199910
200021
200120
200310
200410
200540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201110
201220
201310
201410
201910
202010
FIG. 1 — Lineage of K062579, 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? (5)

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
*K051102Omnipicc PI
Summary page 1
…Manufacturer 510(k)# Equivalent Device I OmniPlCC PI MCatheter RITA Medical Systems K051102 PowerPICC TM Catheter Bard Access Systems, Inc K033389, K050931,…
Rita Medical Systems, Inc.2005—
*K033389Powerpicc Catheters, Models 3175155, 3175135
Summary page 1
…I OmniPlCC PI MCatheter RITA Medical Systems K051102 PowerPICC TM Catheter Bard Access Systems, Inc K033389, K050931, K051672, &K051991 Device Description:…
C.R. Bard, Inc.20041
*K0509316 FR DL Powerpicc Catheter
Summary page 1
…OmniPlCC PI MCatheter RITA Medical Systems K051102 PowerPICC TM Catheter Bard Access Systems, Inc K033389, K050931, K051672, &K051991 Device Description: Other Omn…
C.R. Bard, Inc.2005—
*K051672Powerpicc
Summary page 1
…PowerPICC TM Catheter Bard Access Systems, Inc K033389, K050931, K051672, &K051991 Device Description: Other OmniPICC P.I product codes were cleared previously under 510(k) K051102.The purpose of this…
Bard Access Systems, Inc.20051
*K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line
Summary page 1
…PowerPICC TM Catheter Bard Access Systems, Inc K033389, K050931, K051672, &K051991 Device Description: Other OmniPICC P.I product codes were cleared previously under 510(k) K051102.The purpose of this 5 10(k) is…
C.R. Bard, Inc.2005—

Also cleared against K051102: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K071875V-Cath Poly PiccHdc Corp.20079
K101329Synergy CT PiccHealth Line International Corporation20106

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 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 10 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K071875 (Hdc Corp., 2007) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K051102.

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.

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 OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec to 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.

Indications for use as stated in the FDA summary.

Also cleared against K051102

2 other devices cite the same predicate.

  • K101329Synergy CT PiccHealth Line International Corporation · 2010
  • K071875V-Cath Poly PiccHdc Corp. · 2007

More from Rita Medical Systems, Inc.

9 FDA decisions under this applicant name. See the company

  • K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc. · 2007
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 20072 recalls
  • K051102Omnipicc PIRita Medical Systems, Inc. · 2005
  • K050176Vortex EZ Vascular Access PortRita Medical Systems, Inc. · 2005
  • K032149Rita Model 1500X Electrosurgical RF GeneratorRita Medical Systems, Inc. · 2003

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/K062579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062579: Omnipicc P.I..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062579

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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