510(k) · Cleared
Recalled · Class II · 2018Picc Convenience Kit
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 Aug 3, 2012 as substantially equivalent to K111906 (Navilyst Medical, Inc., 2011) and 5 other predicates after a 28-day review. Its family tree reaches back 10 generations to 2000. 2 of the 42 devices in its family, counting itself, have a Class I recall. It has been recalled 17 times.
- Decided
- Aug 3, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 17
- Predicates
- 6
Its longest line of descent runs back 10 generations to K001901 (2000). 41 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 1 generation backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- This deviceK121990 Picc Convenience KitNavilyst Medical, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 1 generation backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- This deviceK121990 Picc Convenience KitNavilyst Medical, Inc. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −5 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −4 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −3 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −2 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −1 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| 0 (this device) | K121990 | Picc Convenience Kit | Navilyst Medical, Inc. | 2012 | — |
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 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K111906 | Xcela Hybrid Picc with Pasv Valve TechnologySummary page 1…term greater than 30 days 21 CFR §880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description… | 2011 |
| * | K101326 | NMI ICSummary page 1…term greater than 30 days 21 CFR §880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description The P1CC… | 2010 |
| * | K093366 | Nmi Picc IISummary page 1…eater than 30 days 21 CFR §880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description The P1CC Convenien… | 2009 |
| * | K091261 | Nmi PiccSummary page 1…n 30 days 21 CFR §880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description The P1CC Convenience Kit in… | 2009 |
| * | K070002 | Boston Scientific Peripherally Inserted Central CatheterSummary page 1…21 CFR §880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description The P1CC Convenience Kit includes pa… | 2007 |
| * | K021704 | Vaxcel Picc with Pasv Valve TechnologySummary page 1…880.5970, Class 11 Premarket Notification K1 11906, K 101326, K093366, K091261, K070002, K02 1704 E. Device Description The P1CC Convenience Kit includes packaging configurations that will accommodate a specified NMI… | 2002 |
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 |
|---|---|---|---|---|
| Oct 16, 2018 | Class II | Z-0596-2019 | 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… |
| May 10, 2018 | Class II | Z-2213-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2201-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2200-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2216-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| Aug 25, 2014 | Class II | Z-0025-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0027-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0035-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0026-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0028-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0031-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0032-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0033-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0034-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0036-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0029-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
| Aug 25, 2014 | Class II | Z-0030-2015 | Nonconforming Material/Component | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity… |
The 5 latest of 17 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 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 15 of the 41 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K111906.
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. 2012, 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid P1CC with PASV Valve Technology is 6 mL/sec. for short or long-term peripheral…
Read the full statement (157 words)
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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid P1CC with PASV Valve Technology is 6 mL/sec.
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.
for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121990: Picc Convenience Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121990
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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