510(k) · Cleared

Recalled · 2005

Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238

K031844510(k) SpecialCleared Jul 15, 200329-day reviewClass II21 CFR 880.5965Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jul 15, 2003 as substantially equivalent to K030083 (Boston Scientific Corp, 2003) after a 29-day review. Its family tree reaches back 1 generation to 2003. 6 later devices descend from it. It has been recalled 3 times.

Decided: Jul 15, 2003
Review: 29 days
Class: Class II
Product code: LJT
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K030083 (2003). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK030083 Vaxcel with Pasv PortBoston Scientific Corp · 2003 · Recalled
This deviceK031844 Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238Boston Scientific Corp · 2003
Descendant · cites it directly · 5 of its ownK032375 Vaxcel Port, Models 45-336 and 45-338Boston Scientific Corp · 2003 · Recalled
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

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all

K032375Vaxcel Port, Models 45-336 and 45-338Boston Scientific Corp · 2003 · cites it directly5descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030083	Vaxcel with Pasv Port	Boston Scientific Corp	2003	21
0 (this device)	K031844	Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238	Boston Scientific Corp	2003	—
+1	K032375	Vaxcel Port, Models 45-336 and 45-338	Boston Scientific Corp	2003	3
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2013	2	0
2015	1	0
2020	1	0

FIG. 1 — Lineage of K031844, 2003–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K030083	Vaxcel with Pasv Port Summary page 1 …port system Provisions Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT Name of VaxcelTM with PASV Port (K030083) Predicate Devices Classification Class I1 Performance Performance Standards have not been established…	Boston Scientific Corp	2003	21

Also cleared against K030083: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K032375	Vaxcel Port, Models 45-336 and 45-338	Boston Scientific Corp	2003	5
K032600	Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233	Boston Scientific Corp	2003	4
K122767	Nmi Port	Navilyst Medical, Inc.	2013	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 25, 2005	Not classified	Z-0782-05	Other	Potential separation of the port base from the port cover after implantation.
Feb 25, 2005	Not classified	Z-0781-05	Other	Potential separation of the port base from the port cover after implantation.
Feb 10, 2004	Not classified	Z-0733-04	Other	Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K032375 (Boston Scientific Corp, 2003) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K030083.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJT

2in 2025

2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007high 182 (2016) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJT

1in 2022

2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007high 4,308 (2025) · low 135 (2016)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 VaxcelTM 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/K031844 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031844: Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031844

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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