510(k) Report

510(k) · Cleared

Recalled · 2011

Lifecath S Picc and Midline Catheter

K062425510(k) SpecialCleared Sep 15, 200628-day reviewClass II21 CFR 880.5970Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Sep 15, 2006 as substantially equivalent to K030270 (Medcomp, 2003) and 3 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 2 times.

Decided
Sep 15, 2006
Review
28 days
Class
Class II
Product code
LJS
Recalls
2
Predicates
4

Its longest line of descent runs back 1 generation to K903648 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestorK903648 · Vygon Lifevac Picc · Vygon Corp. · 19911990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K903648 · Vygon Lifevac Picc · Vygon Corp. · 19910
  1. Root · 1 generation backK903648 Vygon Lifevac PiccVygon Corp. · 1991
  2. This deviceK062425 Lifecath S Picc and Midline CatheterVygon Corp. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903648Vygon Lifevac PiccVygon Corp.1991—
0 (this device)K062425Lifecath S Picc and Midline CatheterVygon Corp.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200310
FIG. 1 — Lineage of K062425, 1991–2006Source: 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? (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
*K0302703F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc…
Summary page 1
…Classification Name: Percutaneous, implanted, long-term intravascular catheter Classification: Class II Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442) Device…
Medcomp2003—
*K903648Vygon Lifevac Picc
Summary page 1
…ed, long-term intravascular catheter Classification: Class II Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442) Device Description: The Lifecath S peripherally inserted ce…
Vygon Corp.1991—
*K983544Vygon Double Lumen Picc-Catheters (4FR. and 5FR.)
Summary page 1
…m intravascular catheter Classification: Class II Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442) Device Description: The Lifecath S peripherally inserted central cathet…
Vygon Corp.1999—
*K993442Vygon Lifecath-Picc (Pur) Catheters (Single and Double Lumen 3FR, 4FR, 4.5FR, and 5FR)
Summary page 1
…ass II Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442) Device Description: The Lifecath S peripherally inserted central catheters and midline catheters are fabrica…
Vygon Corp.2000—

Also cleared against K030270: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 26, 2011Not classifiedZ-2699-2011OtherPeripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
Apr 26, 2011Not classifiedZ-2700-2011OtherPeripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • 3 other devices also cite its predicate K030270.

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 Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.

Indications for use as stated in the FDA summary.

Also cleared against K030270

3 other devices cite the same predicate.

  • K171994Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated · 2018
  • K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
  • K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003

More from Vygon Corp.

48 FDA decisions under this applicant name. See the company

  • K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012
  • K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp. · 2011
  • K073493Hepatostat SetVygon Corp. · 2008
  • K070705Modification to: Latex-Free Bionector, Model# 896.019, 896.039Vygon Corp. · 200713 recalls
  • K061796Hepatostat Set, Model 760XVygon Corp. · 2006

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/K062425 · printed Nov 3, 2026

Cite this page

510(k) Report. “K062425: Lifecath S Picc and Midline Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062425

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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