510(k) · Cleared

Recalled · 2005

Catheter Innovations Implantable Port

K991897510(k) TraditionalCleared Oct 21, 1999139-day reviewClass II21 CFR 880.5965Recalls 9

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

Catheter Innovations, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Oct 21, 1999 as substantially equivalent to K880571 (Catheter Technology Corp., 1988) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it. It has been recalled 9 times.

Decided: Oct 21, 1999
Review: 139 days
Class: Class II
Product code: LJT
Recalls: 9
Predicates: 2

Its longest line of descent runs back 1 generation to K873213 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK873213 Hickman Plastic Subcutaneous PortC.R. Bard, Inc. · 1987 · Recalled
This deviceK991897 Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999
Descendant · cites it directly · 0 of its ownK993860 Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K993860Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873213	Hickman Plastic Subcutaneous Port	C.R. Bard, Inc.	1987	3
0 (this device)	K991897	Catheter Innovations Implantable Port	Catheter Innovations, Inc.	1999	—
+1	K993860	Catheter Innovations Implantable Port	Catheter Innovations, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K991897, 1987–1999Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K880571	Cath-Tech Port Implantable Vascular Access System Summary page 1 …5§10(k) Submissions for Implanted Infusion Ports” by the CDRH, ODE, Division of Gastroenterology/Urology and General Use Devices (October 1990) 5. Predicate Device(s): K880571 — Originally submitted as Catheter Technologies Port Implantable Vascular Access System (Approved to market March 4, 1988) — Curr…	Catheter Technology Corp.	1988	—
*	K873213	Hickman Plastic Subcutaneous Port Summary page 1 …mplantable Vascular Access System (Approved to market March 4, 1988) — Currently marketed by Bard Access Systems as “BardPort™ Implanted Ports with Groshong® catheters” K873213 - Hickman® Subcutaneous Port currently marketed by Bard Access Systems o ] 6. Device Description: Catheter Innovations, Inc. I…	C.R. Bard, Inc.	1987	3

Also cleared against K880571: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993860	Catheter Innovations Implantable Port	Catheter Innovations, Inc.	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 28, 2005	Not classified	Z-0344-06	Other	Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Oct 28, 2005	Not classified	Z-0343-06	Other	Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Jul 22, 2005	Not classified	Z-1516-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005	Not classified	Z-1512-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005	Not classified	Z-1513-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005	Not classified	Z-1515-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005	Not classified	Z-1514-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Jul 22, 2005	Not classified	Z-1517-05	Other	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Mar 29, 2004	Not classified	Z-0847-04	Other	Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K993860 (Catheter Innovations, Inc., 1999) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K880571.

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 Catheter Innovations Implantable Port is designed for 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. It is also indicated for blood specimen withdrawal.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991897 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991897: Catheter Innovations Implantable Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991897

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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