510(k) · Cleared
Recalled · 2005Vaxcel Port, Models 45-336 and 45-338
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Aug 19, 2003 as substantially equivalent to K031844 (Boston Scientific Corp, 2003) after an 18-day review. Its family tree reaches back 2 generations to 2003. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 19, 2003
- Review
- 18 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030083 (2003). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK030083 Vaxcel with Pasv PortBoston Scientific Corp · 2003 · Recalled
- 1 generation backK031844 Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238Boston Scientific Corp · 2003 · Recalled
- This deviceK032375 Vaxcel Port, Models 45-336 and 45-338Boston Scientific Corp · 2003
- Descendant · cites it directly · 4 of its ownK032600 Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233Boston Scientific Corp · 2003 · Recalled
- Descendant · cites it directly · 3 of its ownK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK190559 SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK153228 NMI Port, NMI Port IINavilyst Medical, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K032600Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233Boston Scientific Corp · 2003 · cites it directly4descendants
- K122767Nmi PortNavilyst Medical, Inc. · 2013 · cites it directly3descendants
- K131694Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · 2 generations on2descendants
- K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020 · 3 generations on0descendants
- K153228NMI Port, NMI Port IINavilyst Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030083 | Vaxcel with Pasv Port | Boston Scientific Corp | 2003 | 21 |
| −1 | K031844 | Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238 | Boston Scientific Corp | 2003 | 3 |
| 0 (this device) | K032375 | Vaxcel Port, Models 45-336 and 45-338 | Boston Scientific Corp | 2003 | — |
| +1 | K032600 | Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233 | Boston Scientific Corp | 2003 | 4 |
| +1 | K122767 | Nmi Port | Navilyst Medical, Inc. | 2013 | 6 |
| +2 | K131694 | Nmi Port II Catheter | Navilyst Medical, Inc. | 2013 | 2 |
| +3 | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020 | — |
| +2 | K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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.
Planning a device in LJT? 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 LJT device
- #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031844 | Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238 | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2005 | Not classified | Z-0944-05 | Other | Potential for port housing separation after implantation. |
| Jun 8, 2005 | Not classified | Z-0945-05 | Other | Potential for port housing separation after implantation. |
| Jun 8, 2005 | Not classified | Z-0946-05 | Other | Potential for port housing separation after implantation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 0 years and passes through 1 company; a new generation was cleared every 6 months on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K032600 (Boston Scientific Corp, 2003) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K031844.
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, 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 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Vaxcel™ Port device is intended for use in-patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032375: Vaxcel Port, Models 45-336 and 45-338.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032375
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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