510(k) Report

510(k) · Cleared

Cleared

Angiodynamics, Inc. Morpheus Picc and Procedure Kit

K041420510(k) TraditionalCleared Jul 26, 200459-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

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

Cleared on Jul 26, 2004 after a 59-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 of the 59 devices in its family, counting itself, have a Class I recall. 58 later devices descend from it.

Decided
Jul 26, 2004
Review
59 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
0

58 later devices descend from it, 4 citing it directly. 9 of the 59 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2007: 2 descendants cleared2006: 1 descendant cleared2010: 4 descendants cleared2008: 2 descendants cleared2012: 9 descendants cleared, 3 with a Class I recall32015: 5 descendants cleared2013: 9 descendants cleared, 2 with a Class I recall22009: 2 descendants cleared2011: 1 descendant cleared2016: 6 descendants cleared, 2 with a Class I recall22014: 5 descendants cleared, 1 with a Class I recall12018: 2 descendants cleared2020: 2 descendants cleared2017: 2 descendants cleared2022: 2 descendants cleared, 1 with a Class I recall12025: 4 descendants cleared200020052010201520202025
  1. This deviceK041420 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2004
  2. Descendant · cites it directly · 29 of its ownK070002 Boston Scientific Peripherally Inserted Central CatheterBoston Scientific · 2007
  3. Descendant · 2 generations on · 27 of its ownK091261 Nmi PiccNavilyst Medical, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
  5. Descendant · 2 generations on · 26 of its ownK093366 Nmi Picc IINavilyst Medical, Inc. · 2009
  6. Descendant · 2 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 22010: 42011: 12012: 92013: 92014: 52015: 52016: 62017: 22018: 22020: 22022: 22025: 4
2006high 9 (2012) · low 0 (2019)2026

Class I recalls in this family

  • K113277 Arrowadvantages Pressure Injectable Peripherally…2 generations on · 2012
  • K112896 Arrw Evolution3 generations on · 2012
  • K131260 Nmi Dialysis Catheter3 generations on · 2014
  • K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2012

Most influential descendants

Showing 5 of 58 · See all
  • K070002Boston Scientific Peripherally Inserted Central CatheterBoston Scientific · 2007 · cites it directly29descendants
  • K091261Nmi PiccNavilyst Medical, Inc. · 2009 · 2 generations on27descendants
  • K101326NMI ICNavilyst Medical, Inc. · 2010 · 2 generations on26descendants
  • K093366Nmi Picc IINavilyst Medical, Inc. · 2009 · 2 generations on26descendants
  • K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041420Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc.2004—
+1K070002Boston Scientific Peripherally Inserted Central CatheterBoston Scientific2007—
+2K091261Nmi PiccNavilyst Medical, Inc.20095
+2K101326NMI ICNavilyst Medical, Inc.2010—
+2K093366Nmi Picc IINavilyst Medical, Inc.2009—
+2K121089Nmi Picc IiiNavilyst Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200920
201040
201110
201293
201392
201451
201550
201662
201720
201820
202020
202221
202540
FIG. 1 — Lineage of K041420, 2004–2025Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

9 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (58)

See all 58

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

NumberDeviceApplicantDecidedDescendants
K070002Boston Scientific Peripherally Inserted Central CatheterBoston Scientific200729
K061289Arrow Pressure Injectable PiccArrow International, Inc.200620
K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc.20076
K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.20100

Has anything in its family been recalled? (9 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.

  • K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 5 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 · 5 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 · 6 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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 9; all are on the web page.

What does this lineage say?

  • Of its descendants, K070002 (Boston Scientific, 2007) has gone furthest, with 29 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.

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 AngioDynamics, Inc. Morpheus TM CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. For blood sampling, infusion, or therapy use a 4 French or larger catheter.

Indications for use as stated in the FDA 510(k) statement.

More from AngioDynamics, Inc.

87 FDA decisions under this applicant name. See the company

  • K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025
  • K253106AngioVac CannulaAngioDynamics, Inc. · 2025
  • K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090)…AngioDynamics, Inc. · 2024
  • K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc. · 2024
  • K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc. · 2023

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/K041420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041420: Angiodynamics, Inc. Morpheus Picc and Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041420

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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