510(k) · Cleared

Cleared

Vital-Port Vascular Access System Power Injectable Port

K150733510(k) SpecialCleared May 21, 201562-day reviewClass II21 CFR 880.5965

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

Cook Incorporated · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on May 21, 2015 as substantially equivalent to K081425 (Cook Vascular, Inc., 2008) after a 62-day review. Its family tree reaches back 1 generation to 2008.

Decided: May 21, 2015
Review: 62 days
Class: Class II
Product code: LJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K081425 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK081425 Cook Vascular Inc. Vital-Port Vascular Access System Power…Cook Vascular, Inc. · 2008 · Recalled
This deviceK150733 Vital-Port Vascular Access System Power Injectable PortCook Incorporated · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K081425	Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port	Cook Vascular, Inc.	2008	1
0 (this device)	K150733	Vital-Port Vascular Access System Power Injectable Port	Cook Incorporated	2015	—

FIG. 1 — Lineage of K150733, 2008–2015Source: 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
*	K081425	Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port Summary page 4 …ssion is substantially equivalent to the predicate device, the Vital-Port Vascular Access System Power Injectable Port, cleared on September 30, 2008 under 510(k) number K081425. Technological Characteristics and Comparison to Predicate Device: It has been demonstrated that the proposed Vital-Port Vascul…	Cook Vascular, Inc.	2008	1

Also cleared against K081425: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
1 other device also cites its predicate K081425.

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. 2015, this device’s year, is highlighted.

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 Vital-Port® Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150733: Vital-Port Vascular Access System Power Injectable Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150733

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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