510(k) Report

510(k) · Cleared

Recalled · 2012

Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519

K093406510(k) SpecialCleared Mar 25, 2010143-day reviewClass II21 CFR 880.5970Recalls 38

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 Mar 25, 2010 as substantially equivalent to K070615 (AngioDynamics, Inc., 2007) and 6 other predicates after a 143-day review. Its family tree reaches back 7 generations to 2000. It has been recalled 38 times.

Decided
Mar 25, 2010
Review
143 days
Class
Class II
Product code
LJS
Recalls
38
Predicates
7

Its longest line of descent runs back 7 generations to K001901 (2000). 15 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 3 other ancestors2003: 2 other ancestors2005: 1 other ancestorK001901 · 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. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK053501 · Powerpicc · Bard Access Systems, Inc. · 20062000200220042006200820102012
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 1 other ancestor4 generations back: 1 other ancestor K053501 · Powerpicc · Bard Access Systems, Inc. · 2006K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · 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 backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK053501 PowerpiccBard Access Systems, Inc. · 2006
  8. This deviceK093406 Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. · 2010
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—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K053501PowerpiccBard Access Systems, Inc.2006—
0 (this device)K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
200430
200510
200610
200710
FIG. 1 — Lineage of K093406, 2000–2010Source: 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? (7)

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
*K070615Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit
Summary page 1
…D)6vicc Nami, 510(k) Numbber C6ncurrencc Date AngioDynamics Morpheus® CT PIECC K070615 May 04, 2007 and Procedure Kits K060887…
AngioDynamics, Inc.2007—
*K060887Angiodynamic, Inc. Morpheus CT Picc and Procedure Kit
Summary page 1
…AngioDynamics Morpheus® CT PIECC K070615 May 04, 2007 and Procedure Kits K060887 April 24, 2006 K(041420…
AngioDynamics, Inc.2006—
*K041420Angiodynamics, Inc. Morpheus Picc and Procedure Kit
Summary page 5
…. redlicate K(060887, K(0608.87, Proposed Dbvc. ahee Proposed 6F Device 1K041420, 1(041420, 1K040446,…
AngioDynamics, Inc.2004—
*K040446Angiodynamics, Inc. Morpheus Picc and Procedure Kit
Summary page 1
…K(041420 July 26, 2004 K040446 March 05, 2004 K(031626…
AngioDynamics, Inc.2004—
*K031626Angiodynamics, Inc. Morpheus Picc and Procedure Kit
Summary page 1
…K040446 March 05, 2004 K(031626 June 19, 2003 _____ _____ ____…
AngioDynamics, Inc.2003—
*K030415Angiodynamics, Inc. Morpheus Picc and Procedure Kit
Summary page 1
…June 19, 2003 _____ _____ ____ ____ _____ ____ __ K030415 April 30, 2003 Bard Access Systems, Inc. 6 Fr TL K(053501…
AngioDynamics, Inc.20031
*K053501Powerpicc
Summary page 1
…____ _____ ____ __ K030415 April 30, 2003 Bard Access Systems, Inc. 6 Fr TL K(053501 January 13, 2006 PowcrPICC® Catheter ____________ Contact…
Bard Access Systems, Inc.2006—

Also cleared against K070615: 1 other device →

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
Feb 6, 2012Not classifiedZ-1068-2012Labeling mix-upsThe Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.
Feb 6, 2012Not classifiedZ-1069-2012Labeling mix-upsThe Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.
Jan 9, 2012Not classifiedZ-0884-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0887-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0883-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0878-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0879-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0880-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0888-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0889-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0890-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0893-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0894-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0895-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0897-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0900-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0902-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0904-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0908-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0877-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0881-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0882-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0885-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0886-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0891-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0892-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0896-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0898-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0899-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0901-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0903-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0905-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0906-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0910-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0912-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0907-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0909-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Jan 9, 2012Not classifiedZ-0911-2012Nonconforming Material/ComponentThe red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.

The 5 latest of 38 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 5 of the 15 ancestors have a recall of any class.
  • 1 other device also cites its predicate K070615.

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. 2010, 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 AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Indications for use as stated in the FDA summary.

Also cleared against K070615

1 other device cites the same predicate.

  • K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2007

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/K093406 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093406: Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093406

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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