510(k) · Cleared
ClearedAngiodynamics, Inc. Morpheus Picc and Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 19, 2003 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 19, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031626 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK093406 Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031626 | Angiodynamics, Inc. Morpheus Picc and Procedure Kit | AngioDynamics, Inc. | 2003 | — |
| +1 | K093406 | Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519 | AngioDynamics, Inc. | 2010 | 38 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093406 | Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519 | 2010 | 0 |
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, K093406 (AngioDynamics, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJS devicesLJS 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031626: 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/K031626
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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