510(k) · Cleared
ClearedNylus Picc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Semprus Biosciences · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 6, 2012 as substantially equivalent to K101329 (Health Line International Corporation, 2010) and 2 other predicates after a 371-day review. Its family tree reaches back 11 generations to 2000. 2 of the 36 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 6, 2012
- Review
- 371 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K001901 (2000). 35 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 2 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 1 generation backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- This deviceK113225 Nylus PiccSemprus Biosciences · 2012
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 6 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 5 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 4 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 3 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 2 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 1 generation backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- This deviceK113225 Nylus PiccSemprus Biosciences · 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 |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −6 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −5 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −4 | K062579 | Omnipicc P.I. | Rita Medical Systems, Inc. | 2006 | — |
| −3 | K071875 | V-Cath Poly Picc | Hdc Corp. | 2007 | — |
| −2 | K083873 | Picc (CT Rated and Non-Rated) | Pfm Medical, Inc. | 2009 | 3 |
| −1 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| 0 (this device) | K113225 | Nylus Picc | Semprus Biosciences | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K101329 | Synergy CT PiccSummary page 2…: Peripherally Inserted Central Catheter (PICC) Classification: Sec 880.5970 Percutaneous, implanted, long-term intravascular catheter 5 10(k) Number: K101329 Product Code: US Device Trade Name: ZeusTM CT P1CC Common Name: Peripherally Inserted Central Cathe… | 2010 |
| * | K083763 | Zeus CT Picc 4 FR and 5 FR Single and Dual LumenSummary page 2…Peripherally Inserted Central Catheter (P1CC) Classification: Sec 880.5970 Percutaneous, implanted, long-term intravascular catheter 510(k) Number: K083 763 Product Code: US Device Trade Name: Duraspan Tm Long-term Hemodialysis Catheter Common Name: Long T… | 2009 |
| * | K091506 | Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220…Summary page 2…ysis Catheter Common Name: Long Term Hemodialysis Catheter Classification: Sec 876.5540 Blood access device and accessories 510(k) Number: K09 1506 Product Code: MSD Device Description The NylusTM P1CC is a 5Fr, dual-lumen Peripherally Inserted Central Catheter.… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 12 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 35 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K101329.
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?
The Nylus P1CC is intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus P1CC is indicated for dwell times shorter or greater than 30 days. The device has a maximum recommended infusion rating of 5mL/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113225: Nylus Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113225
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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