510(k) · Cleared
Recalled · Class II · 2018Nmi Picc
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 May 12, 2009 as substantially equivalent to K070002 (Boston Scientific, 2007) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 2004. 1 of the 32 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- May 12, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041420 (2004). 4 ancestors in all, the oldest K021704 (2002). 27 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 · 2 generations backK041420 Angiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. · 2004
- 1 generation backK070002 Boston Scientific Peripherally Inserted Central CatheterBoston Scientific · 2007
- This deviceK091261 Nmi PiccNavilyst Medical, Inc. · 2009
- Descendant · cites it directly · 26 of its ownK093366 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
Showing 5 of 27 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 27 · See all- K093366Nmi Picc IINavilyst Medical, Inc. · 2009 · cites it directly26descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041420 | Angiodynamics, Inc. Morpheus Picc and Procedure Kit | AngioDynamics, Inc. | 2004 | — |
| −1 | K070002 | Boston Scientific Peripherally Inserted Central Catheter | Boston Scientific | 2007 | — |
| 0 (this device) | K091261 | Nmi Picc | Navilyst Medical, Inc. | 2009 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K070002 | Boston Scientific Peripherally Inserted Central CatheterSummary page 1…ally Inserted Central Catheter (PICC) Classification Name: UJS- Long terra intravascular catheter, 21 CFR 880.5970, Class II Premnarket Notification(s): K070002, K02 1704 E. Device Description The proposed PICC has similar technological characteristics as the predicate devices. It is… | 2007 |
| * | K021704 | Vaxcel Picc with Pasv Valve TechnologySummary page 1…rted Central Catheter (PICC) Classification Name: UJS- Long terra intravascular catheter, 21 CFR 880.5970, Class II Premnarket Notification(s): K070002, K02 1704 E. Device Description The proposed PICC has similar technological characteristics as the predicate devices. It is a fle… | 2002 |
What descends from it? (27)
See all 275 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2018 | Class II | Z-0595-2019 | Under Investigation by firm | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the… |
| Nov 28, 2016 | Class II | Z-0240-2018 | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of… |
| Nov 28, 2016 | Class II | Z-0242-2018 | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of… |
| Nov 28, 2016 | Class II | Z-0241-2018 | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of… |
| Nov 28, 2016 | Class II | Z-0243-2018 | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of… |
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 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093366 (Navilyst Medical, Inc., 2009) has gone furthest, with 26 descendants of its own.
- 6 other devices also cite its predicate K070002.
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 the 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/K091261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091261: Nmi Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091261
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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