510(k) Report

510(k) · Cleared

Cleared

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

K252373510(k) TraditionalCleared Dec 16, 2025139-day reviewClass II21 CFR 880.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spectrum Vascular · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Dec 16, 2025 as substantially equivalent to K163452 (Navilyst Medical, Inc., 2017) after a 139-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.

Decided
Dec 16, 2025
Review
139 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
1

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.

Other ancestors, by year cleared 2012: 1 other ancestor2009: 3 other ancestors2007: 2 other ancestors2006: 3 other ancestors2004: 4 other ancestors2002: 1 other ancestor2008: 1 other ancestor2001: 4 other ancestors2005: 3 other ancestors2003: 1 other ancestor2000: 2 other ancestors, 1 with a Class I recall11999: 2 other ancestors1997: 2 other ancestors1996: 1 other ancestor1991: 1 other ancestor1983: 1 other ancestor1986: 1 other ancestor, 1 with a Class I recall1K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) K061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 2006K101326 · NMI IC · Navilyst Medical, Inc. · 2010K111906 · Xcela Hybrid Picc with Pasv Valve Technology · Navilyst Medical, Inc. · 2011K122882 · Nmi Hpicc Iii · Navilyst Medical, Inc. · 2012K131038 · Nmi Picc Maximal Barrier Nursing Kits · Navilyst Medical, Inc. · 2013 · recalledK142616 · PICC Maximal Barrier Nursing Kit · Navilyst Medical, Inc. · 2014 · recalledK163452 · PICC Maximal Barrier Nursing Kit · Navilyst Medical, Inc. · 2017 · recalled19801990200020102020
Other ancestors, by generation 4 generations back: 4 other ancestors5 generations back: 4 other ancestors6 generations back: 3 other ancestors7 generations back: 8 other ancestors8 generations back: 12 other ancestors, 1 with a Class I recall19 generations back: 2 other ancestors, 1 with a Class I recall1 K163452 · PICC Maximal Barrier Nursing Kit · Navilyst Medical, Inc. · 2017 · recalledK142616 · PICC Maximal Barrier Nursing Kit · Navilyst Medical, Inc. · 2014 · recalledK131038 · Nmi Picc Maximal Barrier Nursing Kits · Navilyst Medical, Inc. · 2013 · recalledK122882 · Nmi Hpicc Iii · Navilyst Medical, Inc. · 2012K111906 · Xcela Hybrid Picc with Pasv Valve Technology · Navilyst Medical, Inc. · 2011K101326 · NMI IC · Navilyst Medical, Inc. · 2010K061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 2006K051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−10−50
  1. Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 10 generations between
  3. 3 generations backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
  4. 2 generations backK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014 · Recalled
  5. 1 generation backK163452 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2017 · Recalled
  6. This deviceK252373 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology…Spectrum Vascular · 2025
Show all 14 generations
  1. Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 13 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 12 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 11 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 10 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 9 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 8 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 7 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  9. 6 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
  10. 5 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
  11. 4 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
  12. 3 generations backK131038 Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 2013 · Recalled
  13. 2 generations backK142616 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2014 · Recalled
  14. 1 generation backK163452 PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 2017 · Recalled
  15. This deviceK252373 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology…Spectrum Vascular · 2025

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…8 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip9 generations back · 1986
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−13K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−12K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−11K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−10K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−9K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−8K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−7K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—
−6K101326NMI ICNavilyst Medical, Inc.2010—
−5K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.2011—
−4K122882Nmi Hpicc IiiNavilyst Medical, Inc.2012—
−3K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.201312
−2K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201413
−1K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.20175
0 (this device)K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo…Spectrum Vascular2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199110
199610
199720
199920
200021
200140
200210
200310
200440
200530
200630
200720
200810
200930
201210
FIG. 1 — Lineage of K252373, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K163452PICC Maximal Barrier Nursing Kit
Summary page 7
…PICC Maximal Barrier Nursing Kits Common Name: Peripherally Inserted Central Catheter (PICC) 510(k) Number: K163452 Manufacturer: Navilyst Medical, Inc. The predicate device has not been subject to…
Navilyst Medical, Inc.20175

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 · 8 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 · 9 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 18 of the 47 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · LJS

8in 2025

2007: 142008: 42009: 162010: 92011: 62012: 142013: 142014: 82015: 72016: 92017: 72018: 102020: 22021: 32022: 32023: 42024: 12025: 82026 (partial year): 2
2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007: 92 days median2008: 97 days median2009: 70 days median2010: 114 days median2011: 55 days median2012: 77 days median2013: 31 days median2014: 47 days median2015: 71 days median2016: 128 days median2017: 101 days median2018: 148 days median2021: 284 days median2022: 177 days median2023: 47 days median2025: 171 days median
2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2008: 12009: 12010: 122011: 42012: 402014: 152015: 22016: 182017: 92018: 32021: 12023: 5, 2 Class I2026 (partial year): 8, 1 Class I
2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007: 3922008: 3692009: 3792010: 4952011: 6962012: 5642013: 6802014: 8422015: 1,3062016: 1,1232017: 2,1002018: 2,3242019: 2,0522020: 2,5392021: 3,0842022: 3,2562023: 2,7992024: 4,2432025: 4,372
2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714920392
20084971369
200916701379
2010911412495
20116554696
2012147740564
201314310680
201484715842
201577121,306
20169128181,123
2017710192,100
20181014832,324
20190—02,052
20202—02,539
2021328413,084
2022317703,256
20234475 (2)2,799
20241—04,243
2025817104,372
20262—8 (1)—

What is it indicated for?

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology The BioFlo Hybrid PICC with ENDEXO 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…

Read the full statement (660 words)

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology

The BioFlo Hybrid PICC with ENDEXO 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. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

• 6F Triple Lumen / 55 cm - 6 mL/sec

BioFlo PICC with ENDEXO and PASV Valve Technology

The BioFlo PICC with ENDEXO 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. 6F catheter is indicated for patients weighing >10 kg.

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

BioFlo PICC with ENDEXO Technology

The 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, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.

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

BioFlo Midline Catheter

The 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 Rate:

• 3F Single Lumen/20 cm - 2 mL/sec

• 4F Single Lumen/20 cm - 6 mL/sec

• 5F Single Lumen/20 cm - 6 mL/sec

• 5F Dual Lumen/20 cm - 6 mL/sec

Xcela Power Injectable PICC

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. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

• 4F Single Lumen/45 cm - 4 mL/sec

• 4F Single Lumen/55 cm - 3.5 mL/sec

• 5F Single Lumen/55 cm - 5 mL/sec

• 5F Dual Lumen/45 cm - 5 mL/sec

• 5F Dual Lumen/55 cm - 4 mL/sec

• 6F Dual Lumen/55 cm - 5 mL/sec

Xcela PICC with PASV Valve Technology

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. 6F catheter is indicated for patients weighing >10 kg.

Xcela Hybrid PICC with PASV Technology

The 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. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

• 6F Triple Lumen/55 cm - 6 mL/sec

Indications for use as stated in the FDA summary.

More from Spectrum Vascular

6 FDA decisions under this applicant name. See the company

  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250724Intraosseous Infusion NeedlesSpectrum Vascular · 2025
  • K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterSpectrum Vascular · 2024

Recent decisions in LJS

The LJS category page

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
  • K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025
  • K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM)…Access Vascular, Inc. · 2025

https://510kreport.com/device/K252373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K252373: BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252373

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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