510(k) Report

510(k) · Cleared

Cleared

NMI IC

K101326510(k) AbbreviatedCleared Sep 2, 2010114-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

Navilyst Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Sep 2, 2010 as substantially equivalent to K070002 (Boston Scientific, 2007) and 5 other predicates after a 114-day review. Its family tree reaches back 8 generations to 2000. 3 of the 63 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.

Decided
Sep 2, 2010
Review
114 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
6

Its longest line of descent runs back 8 generations to K001901 (2000). 36 ancestors in all, the oldest K830256 (1983). 26 later devices descend from it, 3 citing it directly. 3 of the 63 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2001: 4 other ancestors2006: 3 other ancestors2005: 3 other ancestors2004: 4 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 recall12011: 1 descendant cleared2012: 3 descendants cleared2013: 4 descendants cleared2015: 5 descendants cleared2018: 1 descendant cleared2014: 3 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2025: 4 descendants clearedK001901 · 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. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors3 generations back: 12 other ancestors, 1 with a Class I recall14 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 3 descendants2 generations forward: 7 descendants, 1 with a Class I recall13 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 2 descendants K061179 · 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−50+5
  1. Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 1 generation backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  9. This deviceK101326 NMI ICNavilyst Medical, Inc. · 2010
  10. Descendant · cites it directly · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
  11. Descendant · cites it directly · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
  12. Descendant · 2 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
  13. Descendant · 2 generations on · 7 of its ownK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
  14. Descendant · 3 generations on · 6 of its ownK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32013: 42014: 32015: 52016: 12017: 12018: 12020: 22022: 12025: 4
2011high 5 (2015) · low 0 (2019)2026

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip4 generations back · 1986
  • K131260 Nmi Dialysis Catheter2 generations on · 2014

Most influential descendants

Showing 5 of 26 · See all
  • K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · cites it directly23descendants
  • K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · cites it directly14descendants
  • K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 2 generations on12descendants
  • K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013 · 2 generations on7descendants
  • K133264Nmi Picc IiiNavilyst Medical, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−7K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−6K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−5K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−4K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−3K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−2K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−1K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—
0 (this device)K101326NMI ICNavilyst Medical, Inc.2010—
+1K121089Nmi Picc IiiNavilyst Medical, Inc.2012—
+1K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.2011—
+2K122882Nmi Hpicc IiiNavilyst Medical, Inc.2012—
+2K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.2013—
+3K133264Nmi Picc IiiNavilyst Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199110
199610
199720
199920
200021
200140
200310
200440
200530
200630
200720
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201340
201431
201550
201610
201710
201810
202020
202210
202540
FIG. 1 — Lineage of K101326, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

3 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070002Boston Scientific Peripherally Inserted Central Catheter
Summary page 1
…Intravascular Catheter Classification Name: Short & Long-Term Intravascular Catheter; 2ICER §880.5970, Class 11 Premarket Notification(s): K070002 Classification Panel: General Hospital Navilyst Medical, Inc. Central Venous Cathet…
Boston Scientific2007—
*K003839Central Venous Catheter
Summary page 1
…Intravascular Catheter Short & Long-Term Intravascular Catheter; 21 CFR §880.5970, Class II K003 839 General Hospital Bard Power PICC…
Boston Scientific Corp2001—
*K0709964 FR Single Lumen (SL) Powerpicc Catheter
Summary page 1
…Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070996, K051991 General Hospital Bard PowerLine Central Venous Cat…
C.R. Bard, Inc.2007—
*K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line
Summary page 1
…Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070996, K051991 General Hospital Bard PowerLine Central Venous Catheter…
C.R. Bard, Inc.2005—
*K061179Powerhickman Long-Term Intravascular Catheter
Summary page 2
…Intravascular Catheter Short and Long-Term Intravascular Catheter; 21ICFR §880.5970, Class 11 K061 179 General Hospital Cook Spectrum and Spectrum Glide Central Venous…
C.R. Bard, Inc.2006—
*K081113Cook and Cook Spectrum Central Venous Catheters
Summary page 2
…ok Spectrum and Spectrum Glide Central Venous Catheters Intravascular Catheter; 2ICFR §880.5200, Class II K08 1113 General Hospital E. Device Description The NMI IC has an open ended lumen with proximally l…
Cook, Inc.2008105

Also cleared against K070002: 6 other devices →

What descends from it? (26)

See all 26

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121089Nmi Picc IiiNavilyst Medical, Inc.201223
K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114
K121990Picc Convenience KitNavilyst Medical, Inc.20120

Has anything in its family been recalled? (3 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 · 3 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 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 13 of the 36 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K121089 (Navilyst Medical, Inc., 2012) has gone furthest, with 23 descendants of its own.
  • 6 other devices also cite its predicate K070002.

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. 2010, 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?

The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) 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.

Indications for use as stated in the FDA summary.

Also cleared against K070002

6 other devices cite the same predicate.

  • K150527Xcela Power Injectable PICCNavilyst Medical, Inc. · 2015
  • K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc. · 201312 recalls
  • K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012
  • K121990Picc Convenience KitNavilyst Medical, Inc. · 201217 recalls
  • K093366Nmi Picc IINavilyst Medical, Inc. · 2009
  • K091261Nmi PiccNavilyst Medical, Inc. · 20095 recalls

More from Navilyst Medical, Inc.

35 FDA decisions under this applicant name. See the company

  • K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc. · 20175 recalls
  • K161866BioFlo Midline CatheterNavilyst Medical, Inc. · 20163 recalls
  • K151239Nmi Dual Port IINavilyst Medical, Inc. · 2016
  • K153228NMI Port, NMI Port IINavilyst Medical, Inc. · 2015
  • K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc. · 20156 recalls

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
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • 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

https://510kreport.com/device/K101326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101326: NMI IC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101326

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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