510(k) Report

510(k) · Cleared

Cleared

Omnipicc PI

K051102510(k) TraditionalCleared Nov 23, 2005208-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 23, 2005 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) after a 208-day review. Its family tree reaches back 4 generations to 2000. 11 later devices descend from it.

Decided
Nov 23, 2005
Review
208 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K001901 (2000). 11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2007: 1 descendant cleared2006: 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 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants K033389 · 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 · recalled0
  1. Root · 4 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 3 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 2 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 1 generation backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. This deviceK051102 Omnipicc PIRita Medical Systems, Inc. · 2005
  6. Descendant · cites it directly · 10 of its ownK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
  7. Descendant · cites it directly · 9 of its ownK071875 V-Cath Poly PiccHdc Corp. · 2007
  8. Descendant · 2 generations on · 8 of its ownK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
  9. Descendant · cites it directly · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
  10. Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 12010: 12011: 12012: 22013: 12014: 12019: 12020: 1
2006high 2 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all
  • K062579Omnipicc P.I.Rita Medical Systems, Inc. · 2006 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−3K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−2K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−1K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
0 (this device)K051102Omnipicc PIRita Medical Systems, Inc.2005—
+1K062579Omnipicc 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200910
201010
201110
201220
201310
201410
201910
202010
FIG. 1 — Lineage of K051102, 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.

Planning a device in LJS? 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? (1)

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
*K033389Powerpicc Catheters, Models 3175155, 3175135
Summary page 1
…ct Manufacturer 510(k) # £:;quivalent Device ',: ~~~~PowerPICC m Catheter Bard Access Systems, Inc K033389 Device Description: The Peripherally Inserted Central Catheter (OmniPICC P.1.) kit includes a catheter and introduction componen…
C.R. Bard, Inc.20041

Also cleared against K033389: 10 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K062579Omnipicc P.I.Rita Medical Systems, Inc.200610
K071875V-Cath Poly PiccHdc Corp.20079
K101329Synergy CT PiccHealth Line International Corporation20106

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K062579 (Rita Medical Systems, Inc., 2006) has gone furthest, with 10 descendants of its own.
  • 10 other devices also cite its predicate K033389.

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 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 K033389

10 other devices cite the same predicate.

  • K102159Powerpicc SV CathetersC.R. Bard, Inc. · 20103 recalls
  • K071875V-Cath Poly PiccHdc Corp. · 2007
  • K072230Powerpicc SoloC.R. Bard, Inc. · 20074 recalls
  • K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  • K062579Omnipicc P.I.Rita Medical Systems, Inc. · 2006
  • K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 20061 recall

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
  • K062579Omnipicc P.I.Rita Medical Systems, Inc. · 2006
  • 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/K051102 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051102: Omnipicc PI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051102

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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