510(k) Report

510(k) · Cleared

Cleared

Angiodynamics, Inc Morpheus Picc and Procedure Kit

K072196510(k) SpecialCleared Aug 27, 200720-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 Aug 27, 2007 as substantially equivalent to K041420 (AngioDynamics, Inc., 2004) and 3 other predicates after a 20-day review. Its family tree reaches back 1 generation to 2004. 6 later devices descend from it.

Decided
Aug 27, 2007
Review
20 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K041420 (2004). 4 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2006: 1 other ancestor2010: 1 descendant cleared2016: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant clearedK041420 · Angiodynamics, Inc. Morpheus Picc and Procedure Kit · AngioDynamics, Inc. · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants K041420 · Angiodynamics, Inc. Morpheus Picc and Procedure Kit · AngioDynamics, Inc. · 20040
  1. Root · 1 generation backK041420 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2004
  2. This deviceK072196 Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2007
  3. Descendant · cites it directly · 5 of its ownK102159 Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK162443 PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK162441 PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017
  6. Descendant · 2 generations on · 1 of its ownK123617 3F Pro-PiccMedical Components, Inc. · 2013
  7. Descendant · 3 generations on · 0 of its ownK180548 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12013: 22016: 12017: 12018: 1
2010high 2 (2013) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K102159Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · cites it directly5descendants
  • K162443PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · 2 generations on2descendants
  • K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017 · 3 generations on1descendant
  • K1236173F Pro-PiccMedical Components, Inc. · 2013 · 2 generations on1descendant
  • K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd) · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K041420Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc.2004—
0 (this device)K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc.2007—
+1K102159Powerpicc SV CathetersC.R. Bard, Inc.20103
+2K162443PowerPICC Provena CathetersC.R. Bard, Inc.20161
+3K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.2017—
+2K1236173F Pro-PiccMedical Components, Inc.2013—
+3K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen…C.R. Bard, Inc (Bard Has Joined Bd)20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201320
201610
201710
201810
FIG. 1 — Lineage of K072196, 2004–2018Source: 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
*K041420Angiodynamics, Inc. Morpheus Picc and Procedure Kit
Summary page 1
…US Regulatory Class: II Legallv marketed device to which equivalence is claimed: AngioDynamics, Inc. Morpheus PICC and Procedure Kit, 510(k) K041420, K060887, K070613, K070615) Intended Use / Indications The AngioDynamics, Inc. Morpheus" CT PICC and Procedure Kit is indicated…
AngioDynamics, Inc.2004—
*K060887Angiodynamic, Inc. Morpheus CT Picc and Procedure Kit
Summary page 1
…US Regulatory Class: II Legallv marketed device to which equivalence is claimed: AngioDynamics, Inc. Morpheus PICC and Procedure Kit, 510(k) K041420, K060887, K070613, K070615) Intended Use / Indications The AngioDynamics, Inc. Morpheus" CT PICC and Procedure Kit is indicated for short…
AngioDynamics, Inc.2006—
*K070613Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit
Summary page 1
…egulatory Class: II Legallv marketed device to which equivalence is claimed: AngioDynamics, Inc. Morpheus PICC and Procedure Kit, 510(k) K041420, K060887, K070613, K070615) Intended Use / Indications The AngioDynamics, Inc. Morpheus" CT PICC and Procedure Kit is indicated for short or long…
AngioDynamics, Inc.2007—
*K070615Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit
Summary page 1
…Class: II Legallv marketed device to which equivalence is claimed: AngioDynamics, Inc. Morpheus PICC and Procedure Kit, 510(k) K041420, K060887, K070613, K070615) Intended Use / Indications The AngioDynamics, Inc. Morpheus" CT PICC and Procedure Kit is indicated for short or long term peri…
AngioDynamics, Inc.2007—

Also cleared against K041420: 3 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102159Powerpicc SV CathetersC.R. Bard, Inc.20105

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K102159 (C.R. Bard, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K041420.

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. 2007, 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® CT PICC 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 K041420

3 other devices cite the same predicate.

  • K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. · 201038 recalls
  • K070002Boston Scientific Peripherally Inserted Central CatheterBoston Scientific · 2007
  • K061289Arrow Pressure Injectable PiccArrow International, Inc. · 200611 recalls

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/K072196 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072196: 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/K072196

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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