510(k) Report

510(k) · Cleared

Cleared

Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit

K070613510(k) TraditionalCleared Jun 29, 2007116-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 Jun 29, 2007 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Jun 29, 2007
Review
116 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared20052010201520202025
  1. This deviceK070613 Angiodynamics, Inc., Morpheus CT Picc and Procedure KitAngioDynamics, Inc. · 2007
  2. Descendant · cites it directly · 6 of its ownK072196 Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2007
  3. Descendant · 2 generations on · 5 of its ownK102159 Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK162443 PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK162441 PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017
  6. Descendant · 3 generations on · 1 of its ownK123617 3F Pro-PiccMedical Components, Inc. · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12013: 22016: 12017: 12018: 1
2007high 2 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2007 · cites it directly6descendants
  • K102159Powerpicc SV CathetersC.R. Bard, Inc. · 2010 · 2 generations on5descendants
  • K162443PowerPICC Provena CathetersC.R. Bard, Inc. · 2016 · 3 generations on2descendants
  • K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. · 2017 · 4 generations on1descendant
  • K1236173F Pro-PiccMedical Components, Inc. · 2013 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070613Angiodynamics, Inc., Morpheus CT Picc and Procedure KitAngioDynamics, Inc.2007—
+1K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc.2007—
+2K102159Powerpicc SV CathetersC.R. Bard, Inc.20103
+3K162443PowerPICC Provena CathetersC.R. Bard, Inc.20161
+4K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.2017—
+3K1236173F Pro-PiccMedical Components, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201320
201610
201710
201810
FIG. 1 — Lineage of K070613, 2007–2018Source: 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 510(k) statement (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?

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

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K072196Angiodynamics, Inc Morpheus Picc and Procedure KitAngioDynamics, Inc.20076

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?

  • Of its descendants, K072196 (AngioDynamics, Inc., 2007) has gone furthest, with 6 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. 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 AngloDynamics, Inc. Morpheus® 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/K070613 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070613: Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070613

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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