510(k) · Cleared
Recalled · 2010Vaxcel with Pasv Port, Model 45-213
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 Jul 14, 2003 after a 14-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 14, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 8
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK032008 Vaxcel with Pasv Port, Model 45-213Boston 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 |
|---|---|---|---|---|---|
| 0 (this device) | K032008 | Vaxcel with Pasv Port, Model 45-213 | 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? (3)
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 |
|---|---|---|---|
| * | — | Vaxcel™ Implantable port system Named without a submission number | |
| * | — | PASVB implantable port system Named without a submission number | |
| * | — | Vaxcel™ with PASVB PICC Named without a submission number |
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 |
|---|---|---|---|---|
| May 13, 2010 | Not classified | Z-1876-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1880-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1879-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1878-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1874-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1877-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| May 13, 2010 | Not classified | Z-1875-2010 | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. |
| Jul 22, 2005 | Not classified | Z-1472-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032600 (Boston Scientific Corp, 2003) has gone furthest, with 4 descendants of its own.
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'M w/ PASVB 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/K032008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032008: Vaxcel with Pasv Port, Model 45-213.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032008
Report an extraction error
Are you the manufacturer?
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