510(k) · Cleared
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 Oct 14, 2014 as substantially equivalent to K131038 (Navilyst Medical, Inc., 2013) after a 28-day review. Its family tree reaches back 12 generations to 2000. 2 of the 48 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 13 times.
- Decided
- Oct 14, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001901 (2000). 45 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 1 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- 2 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 1 generation backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK163452 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK252373 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology…Spectrum Vascular · 2025
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 7 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 6 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 5 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 4 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 3 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- 2 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 1 generation backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −7 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −6 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −5 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −4 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −3 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| −2 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| −1 | K131038 | Nmi Picc Maximal Barrier Nursing Kits | Navilyst Medical, Inc. | 2013 | 12 |
| 0 (this device) | K142616 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2014 | — |
| +1 | K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2017 | 5 |
| +2 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K131038 | Nmi Picc Maximal Barrier Nursing KitsSummary page 7…21 CFR §880.5970, Class II Classification Panel: General Hospital Device Panel Premarket Notification K131038 E. Device Description The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC,… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163452 | PICC Maximal Barrier Nursing Kit | 2017 | 1 |
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-2193-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2194-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2191-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2210-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2203-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2190-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2196-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| May 10, 2018 | Class II | Z-2189-2018 | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| Aug 29, 2016 | Class II | Z-0708-2017 | Under Investigation by firm | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect… |
| Aug 29, 2016 | Class II | Z-0709-2017 | Under Investigation by firm | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect… |
| Aug 29, 2016 | Class II | Z-0710-2017 | Under Investigation by firm | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect… |
| Jun 8, 2016 | Class II | Z-0714-2017 | Mixed-up of materials/components | There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with… |
| Jun 8, 2016 | Class II | Z-0715-2017 | Mixed-up of materials/components | There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with… |
The 5 latest of 13 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 · 6 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 · 7 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 16 of the 45 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K163452 (Navilyst Medical, Inc., 2017) has gone furthest, with 1 descendant 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. 2014, 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 NMI PICC I1I is indicated for short-term 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 mjection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III 1s 6 mL/sec. NON-VALVED VERSION The NMI PICC…
Read the full statement (369 words)
The NMI PICC I1I is indicated for short-term 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 mjection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III 1s 6 mL/sec.
NON-VALVED VERSION
The NMI PICC 111 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 em 1 mL/sec
* 4F Single Lumen/55 cm 3.5 mL/sec
* SF 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
VALVED VERSION
The NMI PICC III 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.
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 Xcela Hybrid PICC with PASV 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 mnjection 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 Valve Technology 1s 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.
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/K142616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142616: PICC Maximal Barrier Nursing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142616
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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