510(k) · Cleared

Recalled · 2004

Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter

K962695510(k) TraditionalCleared Oct 1, 199682-day reviewClass II21 CFR 880.5965Recalls 6

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

Sims Deltec, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Oct 1, 1996 as substantially equivalent to K942024 (Pharmacia Deltec, Inc., 1994) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1994. 19 later devices descend from it. It has been recalled 6 times.

Decided: Oct 1, 1996
Review: 82 days
Class: Class II
Product code: LJT
Recalls: 6
Predicates: 2

Its longest line of descent runs back 1 generation to K932840 (1994). 2 ancestors in all. 19 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932840 Port-a-Cath Implantable Vascular Access SystemPharmacia Deltec, Inc. · 1994 · Recalled
This deviceK962695 Port-a-Cath II Venous Implantable Access Systems Preconnected with…Sims Deltec, Inc. · 1996
Descendant · cites it directly · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
Descendant · 4 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
Descendant · 4 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007high 3 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 19 · See all

K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · cites it directly18descendants
K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 4 generations on2descendants
K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932840	Port-a-Cath Implantable Vascular Access System	Pharmacia Deltec, Inc.	1994	2
0 (this device)	K962695	Port-a-Cath II Venous Implantable Access Systems Preconnected with…	Sims Deltec, Inc.	1996	—
+1	K070116	Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…	Smiths Medical MD, Inc.	2007	—
+2	K073050	Safestep Max Power-Injectable Infusion Set	Specialized Health Products International, Inc.	2008	2
+3	K170897	Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…	B.Braun Medical, Inc.	2017	—
+4	K230715	Promisemed Safety Huber Needle	Promisemed Hangzhou Meditech Co., Ltd.	2023	—
+4	K200463	Huber Needle Infusion Set, Safety Huber Needle Infusion Set	Jiangsu Caina Medical Co.,Ltd	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2014	1	0
2016	1	0
2017	2	0
2020	1	0
2021	3	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K962695, 1994–2026Source: 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
*	K942024	Port-a-Cath Low Profile Implantable Venous Access System Summary page 2 …Dual PORT-A-CATH® Il Systems Preconnected Lumen Systems Systems with with Polyurethane Preconnected with Polyurethane Catheter Catheter Silicone Catheter K932840 K955407 K942024 MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. INDICATIONS FOR USE \| A system is indicated when a \| A system…	Pharmacia Deltec, Inc.	1994	8
*	K932840	Port-a-Cath Implantable Vascular Access System Summary page 2 …PORT-A-CATH® Il Dual PORT-A-CATH® Il Systems Preconnected Lumen Systems Systems with with Polyurethane Preconnected with Polyurethane Catheter Catheter Silicone Catheter K932840 K955407 K942024 MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. INDICATIONS FOR USE \| A system is indicated wh…	Pharmacia Deltec, Inc.	1994	2

Also cleared against K942024: 4 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K070116	Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…	Smiths Medical MD, Inc.	2007	18

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 29, 2004	Not classified	Z-0867-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004	Not classified	Z-0869-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004	Not classified	Z-0870-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004	Not classified	Z-0866-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004	Not classified	Z-0868-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004	Not classified	Z-0876-04	Other	Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K070116 (Smiths Medical MD, Inc., 2007) has gone furthest, with 18 descendants of its own.
4 other devices also cite its predicate K942024.

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?

PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are indicated when a patient requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

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/K962695 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962695: Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962695

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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