510(k) · Decided
Recalled · Class II · 2018PICC Maximal Barrier Nursing 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 Feb 3, 2017 as substantially equivalent to K142616 (Navilyst Medical, Inc., 2014) after a 56-day review. Its family tree reaches back 13 generations to 2000. 2 of the 48 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Feb 3, 2017
- Review
- 56 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 13 generations to K001901 (2000). 46 ancestors in all, the oldest K830256 (1983). 1 later device descends from it, 1 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 2 generations backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
- 1 generation backK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014 · Recalled
- This deviceK163452 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK252373 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology…Spectrum Vascular · 2025
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 8 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 7 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 6 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 5 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 4 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- 3 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 2 generations backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
- 1 generation backK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014 · Recalled
- This deviceK163452 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −8 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −7 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −6 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −5 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −4 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| −3 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| −2 | K131038 | Nmi Picc Maximal Barrier Nursing Kits | Navilyst Medical, Inc. | 2013 | 12 |
| −1 | K142616 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2014 | 13 |
| 0 (this device) | K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2017 | — |
| +1 | K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo… | Spectrum Vascular | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K142616 | PICC Maximal Barrier Nursing KitSummary page 6…evice Panel D. Predicate Device Trade Name: PICC Maximal Barrier Nursing Kits 510(k) Reference: K142616 Common Name: Peripherally Inserted Central Catheter (PICC) Regulation Number:… | 2014 |
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 |
|---|---|---|---|
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with… | 2025 | 0 |
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-2222-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2224-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2223-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2217-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2221-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
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 · 7 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 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 17 of the 46 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K252373 (Spectrum Vascular, 2025) 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. 2017, 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 PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum…
Read the full statement (547 words)
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo 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, for central venous pressure monitoring and for power injection of contrast media.
Maximum Power Injection Flow Rate:
• 3F Single Lumen/55 cm 1 mL/sec
• 4F Single Lumen/55 cm 3.5 mL/sec
• 5F Single Lumen/55 cm 5 mL/sec
• 5F Dual Lumen/55 cm 4 mL/sec
• 6F Dual Lumen/55 cm 5 mL/sec
• 6F Triple Lumen/55 – 6 mL/sec
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and 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.
Maximum Power Injection Flow Rate:
• 3F Single Lumen/55 cm 1 mL/sec
• 4F Single Lumen/55 cm 3.5 mL/sec
• 5F Single Lumen/55 cm 5 mL/sec
• 5F Dual Lumen/55 cm 4 mL/sec
• 6F Dual Lumen/55 cm 5 mL/sec
• 6F Triple Lumen/55 cm 6 mL/sec
The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rates:
• 3F Single Lumen, 20 cm: 2 mL/sec
• 4F Single Lumen, 20 cm: 6 mL/sec
• 5F Single Lumen, 20 cam: 6 mL/sec
• 5F Dual Lumen, 20 cm: 6 mL/sec
The PICC Maximal Barrier Nursing Kit with Xcela Hybrid 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valave Technology is 6 mL/sec.
The PICC Maximal Barrier Nursing Kit with 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 PICC Maximal Barrier Nursing Kit with 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163452 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163452: PICC Maximal Barrier Nursing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163452
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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