510(k) · Cleared
Recalled · Class II · 2016Vaxcel Picc with Pasv Valve Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Innovations, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 6, 2002 after a 14-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 of the 35 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it. It has been recalled 31 times.
- Decided
- Jun 6, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 31
- Predicates
- 1
34 later devices descend from it, 4 citing it directly. 2 of the 35 devices in this family, counting this one, have a Class I recall.
- This deviceK021704 Vaxcel Picc with Pasv Valve TechnologyCatheter Innovations, Inc. · 2002
- Descendant · cites it directly · 27 of its ownK091261 Nmi PiccNavilyst Medical, Inc. · 2009 · Recalled
- Descendant · cites it directly · 26 of its ownK093366 Nmi Picc IINavilyst Medical, Inc. · 2009
- 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
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K091261Nmi PiccNavilyst Medical, Inc. · 2009 · cites it directly27descendants
- K093366Nmi Picc IINavilyst Medical, Inc. · 2009 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021704 | Vaxcel Picc with Pasv Valve Technology | Catheter Innovations, Inc. | 2002 | — |
| +1 | K091261 | Nmi Picc | Navilyst Medical, Inc. | 2009 | 5 |
| +1 | K093366 | Nmi Picc II | Navilyst Medical, Inc. | 2009 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 1 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2025 | 4 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K036421 | PLACEMENT-plus Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…f Safety and Effectiveness G~+neraf Provisions Trade Name: Vaxcel” PlCC Catheter with PASVBTechnology. Name of Predicate PLACEMENT-plusm [KO036421 Device Classification Class ll Performance Performance Standards have not been established by FDA un… |
What descends from it? (34)
See all 344 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2016 | Class II | Z-1985-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1982-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1969-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1971-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1972-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1977-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1975-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1987-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1988-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1973-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1980-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1984-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1966-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1974-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1968-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1976-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1979-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1986-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1970-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1967-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1983-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1978-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Mar 14, 2016 | Class II | Z-1981-2016 | Device Design | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Nov 22, 2004 | Not classified | Z-0403-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0407-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0408-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0409-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0404-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0405-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0410-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
| Nov 22, 2004 | Not classified | Z-0406-05 | Other | Catheter separation immediately distal to the nose of the suture wing. |
The 5 latest of 31 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.
What does this lineage say?
- Of its descendants, K091261 (Navilyst Medical, Inc., 2009) has gone furthest, with 27 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) | — |
What is it indicated for?
The Vaxcel PICC with PASV Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for central venous access in adults, children and infants who require intravenous (IV) therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021704: Vaxcel 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/K021704
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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