510(k) · Cleared
ClearedCentral Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 1, 2001 after a 232-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 28 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 232 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- This deviceK003839 Central Venous CatheterBoston Scientific Corp · 2001
- Descendant · cites it directly · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 2 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- Descendant · 3 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131260 Nmi Dialysis Catheter3 generations on · 2014
Most influential descendants
Showing 5 of 27 · See all- K101326NMI ICNavilyst Medical, Inc. · 2010 · cites it directly26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 2 generations on23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · 2 generations on14descendants
- K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 3 generations on12descendants
- K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003839 | Central Venous Catheter | Boston Scientific Corp | 2001 | — |
| +1 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +2 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +2 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| +3 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| +3 | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | Navilyst Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101326 | NMI IC | 2010 | 26 |
Has anything in its family been recalled? (1 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.
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K101326 (Navilyst Medical, Inc., 2010) has gone furthest, with 26 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.
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) | — |
https://510kreport.com/device/K003839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003839: Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003839
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026