510(k) · Cleared
Recalled · Class II · 2018Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable 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 Sep 24, 2015 as substantially equivalent to K150527 (Navilyst Medical, Inc., 2015) and 2 other predicates after a 29-day review. Its family tree reaches back 14 generations to 2000. 2 of the 48 devices in its family, counting itself, have a Class I recall. It has been recalled 6 times.
- Decided
- Sep 24, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 14 generations to K001901 (2000). 47 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations between
- 3 generations backK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
- 2 generations backK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013
- 1 generation backK150527 Xcela Power Injectable PICCNavilyst Medical, Inc. · 2015
- This deviceK152409 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power…Navilyst Medical, Inc. · 2015
Show all 14 generations
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 13 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 12 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 11 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 10 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 9 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 8 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 7 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 6 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 5 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- 4 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 3 generations backK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
- 2 generations backK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013
- 1 generation backK150527 Xcela Power Injectable PICCNavilyst Medical, Inc. · 2015
- This deviceK152409 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power…Navilyst Medical, Inc. · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −13 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −12 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −11 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −10 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −9 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −8 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −7 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −6 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −5 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| −4 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| −3 | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | Navilyst Medical, Inc. | 2013 | — |
| −2 | K133264 | Nmi Picc Iii | Navilyst Medical, Inc. | 2013 | — |
| −1 | K150527 | Xcela Power Injectable PICC | Navilyst Medical, Inc. | 2015 | — |
| 0 (this device) | K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | Navilyst Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K150527 | Xcela Power Injectable PICCSummary page 4…ral Hospital LIS Peripherally Inserted Central Catheter (PICC) Percutaneous, implanted, long-term intravascular catheter 21CFR§880.5970, Class II General Hospital K150527 (Xcela Power Injectable PICC), K093366 (Xcela PICC w/PASV Valve), KI111906 (Xcela Hybrid PICC w/PASV Valve) E. De… | 2015 |
| * | K093366 | Nmi Picc IISummary page 4…ed Central Catheter (PICC) Percutaneous, implanted, long-term intravascular catheter 21CFR§880.5970, Class II General Hospital K150527 (Xcela Power Injectable PICC), K093366 (Xcela PICC w/PASV Valve), KI111906 (Xcela Hybrid PICC w/PASV Valve) E. Device Description Intended Use The Xcel… | 2009 |
| * | K111906 | Xcela Hybrid Picc with Pasv Valve TechnologySummary page 5…The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink. The proposed device has identical technological ch… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2018 | Class II | Z-2188-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2218-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2219-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2225-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2220-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2212-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
The 5 latest of 6 recalls; the web page lists all.
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.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 15 of the 47 ancestors have a recall of any class; 2 have a Class I recall.
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. 2015, 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?
The Xcela Power Injectable PICC is indicated 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. Maximum Power Injection Flow Rate 4F Single Lumen - 45 cm length 4 mL/sec 5F Dual Lumen - 45 ¢cm length 5 mL/sec 4F Single Lumen - 55 cm length 3.5 mL/sec 5F Dual…
Read the full statement (213 words)
The Xcela Power Injectable PICC is indicated 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.
Maximum Power Injection Flow Rate
4F Single Lumen - 45 cm length 4 mL/sec 5F Dual Lumen - 45 ¢cm length 5 mL/sec
4F Single Lumen - 55 cm length 3.5 mL/sec 5F Dual Lumen - 55 cm length 4 mL/sec
5F Single Lumen - 55 cm length 5 mL/sec 6F Dual Lumen - 55 cm length 5 mL/sec
The Xcela PICC with PASV Valve technology is indicated 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.
The Xcela Hybrid PICC with PASV Valve technology is indicated for short or long-term 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate is 6 mL/sec.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152409: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152409
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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