510(k) Report

510(k) · Cleared

Cleared

Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen

K083763510(k) TraditionalCleared Mar 16, 200988-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

R4 Vascular, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Mar 16, 2009 after an 88-day review. The FDA summary names its predicate without a number. 8 of the 38 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it.

Decided
Mar 16, 2009
Review
88 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
0

37 later devices descend from it, 3 citing it directly. 8 of the 38 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2012: 6 descendants cleared, 2 with a Class I recall22016: 5 descendants cleared, 2 with a Class I recall22013: 7 descendants cleared, 2 with a Class I recall22018: 1 descendant cleared2014: 4 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared2015: 5 descendants cleared2022: 2 descendants cleared, 1 with a Class I recall12017: 1 descendant cleared2025: 4 descendants cleared20052010201520202025
  1. This deviceK083763 Zeus CT Picc 4 FR and 5 FR Single and Dual LumenR4 Vascular, Inc. · 2009
  2. Descendant · cites it directly · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
  3. Descendant · 2 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
  4. Descendant · cites it directly · 12 of its ownK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
  5. Descendant · 2 generations on · 7 of its ownK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
  6. Descendant · 3 generations on · 6 of its ownK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2012: 62013: 72014: 42015: 52016: 52017: 12018: 12020: 22022: 22025: 4
2012high 7 (2013) · low 0 (2019)2026

Class I recalls in this family

  • K112896 Arrw Evolutioncites it directly · 2012
  • K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet2 generations on · 2012
  • K131260 Nmi Dialysis Catheter2 generations on · 2014
  • K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet3 generations on · 2013

Most influential descendants

Showing 5 of 37 · See all
  • K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · cites it directly23descendants
  • K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 2 generations on12descendants
  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly12descendants
  • K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013 · 2 generations on7descendants
  • K133264Nmi Picc IiiNavilyst Medical, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083763Zeus CT Picc 4 FR and 5 FR Single and Dual LumenR4 Vascular, Inc.2009—
+1K121089Nmi Picc IiiNavilyst Medical, Inc.2012—
+2K122882Nmi Hpicc IiiNavilyst Medical, Inc.2012—
+1K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)2012Class I
+2K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.2013—
+3K133264Nmi Picc IiiNavilyst Medical, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201262
201372
201441
201550
201652
201710
201810
202020
202221
202540
FIG. 1 — Lineage of K083763, 2009–2025Source: 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.

8 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? (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
*—V-Cath (Polyurethane) Power PICC (Power-V)
Named without a submission number
—
*—Tyco Palindrome Emerald
Named without a submission number
—

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K121089Nmi Picc IiiNavilyst Medical, Inc.201223
K112896Arrw Evolution Class IArrow International (Subsidiary of Teleflex Inc.)201212
K113225Nylus PiccSemprus Biosciences20120

Has anything in its family been recalled? (8 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.

  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
  • K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
  • K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

  • Of its descendants, K121089 (Navilyst Medical, Inc., 2012) has gone furthest, with 23 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. 2009, 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 Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommednded infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.

Indications for use as stated in the FDA summary.

More from R4 Vascular, Inc.

7 FDA decisions under this applicant name. See the company

  • K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc. · 2013
  • K121385VectorR4 Vascular, Inc. · 2012
  • K100169Duraspan Hemodialysis Long-Term CatheterR4 Vascular, Inc. · 20101 recall
  • K091506Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520R4 Vascular, Inc. · 20101 recall
  • K092040Pherocious 10.5 FR (24 CM, 28 CM and 32 CM), Models 430102440, 430102840, 430103240R4 Vascular, Inc. · 2009

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/K083763 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083763: Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083763

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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