510(k) · Cleared
ClearedNmi Picc II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 24, 2009 as substantially equivalent to K091261 (Navilyst Medical, Inc., 2009) and 2 other predicates after a 26-day review. Its family tree reaches back 3 generations to 2004. 1 of the 32 devices in its family, counting itself, has a Class I recall. 26 later devices descend from it.
- Decided
- Nov 24, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K041420 (2004). 5 ancestors in all, the oldest K021704 (2002). 26 later devices descend from it, 5 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK041420 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2004
- 2 generations backK070002 Boston Scientific Peripherally Inserted Central CatheterBoston Scientific · 2007
- 1 generation backK091261 Nmi PiccNavilyst Medical, Inc. · 2009 · Recalled
- This deviceK093366 Nmi Picc IINavilyst Medical, Inc. · 2009
- Descendant · cites it directly · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- Descendant · 2 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131260 Nmi Dialysis Catheter2 generations on · 2014
Most influential descendants
Showing 5 of 26 · See all- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · cites it directly23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · cites it directly14descendants
- K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 2 generations on12descendants
- K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013 · 2 generations on7descendants
- K133264Nmi Picc IiiNavilyst Medical, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041420 | Angiodynamics, Inc. Morpheus Picc and Procedure Kit | AngioDynamics, Inc. | 2004 | — |
| −2 | K070002 | Boston Scientific Peripherally Inserted Central Catheter | Boston Scientific | 2007 | — |
| −1 | K091261 | Nmi Picc | Navilyst Medical, Inc. | 2009 | 5 |
| 0 (this device) | K093366 | Nmi Picc II | Navilyst Medical, Inc. | 2009 | — |
| +1 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +1 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| +2 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| +2 | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | Navilyst Medical, Inc. | 2013 | — |
| +3 | K133264 | Nmi Picc Iii | Navilyst Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 4 | 0 |
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.
1 device in this family has 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 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091261 | Nmi PiccSummary page 1…g Term Intravascular Therapeutic Catheter Classification Name: 21 CFR § 880,5970, Class 11 Premarket Notification: K091261, K070002, K021704 E. Device Description The proposed Peripherally Inserted Central Catheter is a Flexible radiopaque cathe… | 2009 |
| * | K070002 | Boston Scientific Peripherally Inserted Central CatheterSummary page 1…travascular Therapeutic Catheter Classification Name: 21 CFR § 880,5970, Class 11 Premarket Notification: K091261, K070002, K021704 E. Device Description The proposed Peripherally Inserted Central Catheter is a Flexible radiopaque catheter with… | 2007 |
| * | K021704 | Vaxcel Picc with Pasv Valve TechnologySummary page 1…ar Therapeutic Catheter Classification Name: 21 CFR § 880,5970, Class 11 Premarket Notification: K091261, K070002, K021704 E. Device Description The proposed Peripherally Inserted Central Catheter is a Flexible radiopaque catheter with similar… | 2002 |
What descends from it? (26)
See all 265 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K121089 (Navilyst Medical, Inc., 2012) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K091261.
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. 2009, this device’s year, is highlighted.
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?
For short or long-term peripheral access to tile central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093366 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093366: Nmi Picc II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093366
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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