510(k) · Cleared

Recalled · Class II · 2012

Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached)

K070003510(k) TraditionalCleared May 15, 2007132-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

Medcomp · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on May 15, 2007 as substantially equivalent to K864349 (C.R. Bard, Inc., 1987) and 1 other predicate after a 132-day review. Its family tree reaches back 7 generations to 2000. 20 later devices descend from it. It has been recalled 3 times.

Decided: May 15, 2007
Review: 132 days
Class: Class II
Product code: LJT
Recalls: 3
Predicates: 2

Its longest line of descent runs back 7 generations to K001901 (2000). 21 ancestors in all, the oldest K863606 (1986). 20 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
This deviceK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007
Descendant · cites it directly · 5 of its ownK091099 C-Port - HP Power Injectable PortPhs Medical GmbH · 2009
Descendant · cites it directly · 5 of its ownK072481 Jet Port Plus HP Catheter SystemPfm Medical, Inc. · 2008
Descendant · cites it directly · 5 of its ownK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
Descendant · 2 generations on · 4 of its ownK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
Descendant · 2 generations on · 3 of its ownK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2007high 5 (2013) · low 0 (2010)2026

Most influential descendants

Showing 5 of 20 · See all

K091099C-Port - HP Power Injectable PortPhs Medical GmbH · 2009 · cites it directly5descendants
K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc. · 2008 · cites it directly5descendants
K071993T-Port HP Infusion PortPfm Medical, Inc. · 2007 · cites it directly5descendants
K073210Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007 · 2 generations on4descendants
K122767Nmi PortNavilyst Medical, Inc. · 2013 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−6	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−5	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
−4	K034019	Poly Per-Q-Cath Picc Catheters	C.R. Bard, Inc.	2004	1
−3	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—
−2	K051672	Powerpicc	Bard Access Systems, Inc.	2005	1
−1	K060812	Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple	C.R. Bard, Inc.	2006	1
0 (this device)	K070003	Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…	Medcomp	2007	—
+1	K091099	C-Port - HP Power Injectable Port	Phs Medical GmbH	2009	—
+1	K072481	Jet Port Plus HP Catheter System	Pfm Medical, Inc.	2008	—
+1	K071993	T-Port HP Infusion Port	Pfm Medical, Inc.	2007	—
+2	K073210	Modification to: T-Port HP Infusion Port	Pfm Medical, Inc.	2007	—
+2	K122767	Nmi Port	Navilyst Medical, Inc.	2013	6

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	2	0
1989	4	0
1991	1	0
2000	1	0
2001	1	0
2004	2	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	1	0
2011	4	0
2012	2	0
2013	5	0
2015	1	0
2019	1	0
2020	2	0
2023	1	0

FIG. 1 — Lineage of K070003, 2000–2023Source: 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? (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
*	K864349	Mediport II Single Lum/Port Implant Vasc Acs Port Summary page 1 …C.F.R. Section: 880.5965 Device Classification: II C. Predicate Devices: K864349 Mediport IISingle Lum/Port Vascular Access Port (M.R.I)., Bard Access…	C.R. Bard, Inc.	1987	—
*	K060812	Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple Summary page 1 …Vascular Access Port (M.R.I)., Bard Access Systems K060812, PowerPort Implanted Titanium Port with 8Fr. ChronoFlex& Catheter., Bard…	C.R. Bard, Inc.	2006	1

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K091099	C-Port - HP Power Injectable Port	Phs Medical GmbH	2009	5
K072481	Jet Port Plus HP Catheter System	Pfm Medical, Inc.	2008	5
K071993	T-Port HP Infusion Port	Pfm Medical, Inc.	2007	5
K123292	T3	Medcomp	2013	2
K111101	Norport CT-PC, Lucent Non-Coring Needel Infusion Set	Norfolk Medical	2011	2
K110424	Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…	Medcomp ( Medical Components)	2011	1
K132177	Medcomp Gen Iii Power Injectable Port	Medcomp ( Medical Components)	2013	0
K120281	Dignity Power Injectable Titanium Port	Medical Components, Inc.	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 12, 2012	Not classified	Z-1626-2012	Employee error	50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Apr 2, 2012	Class II	Z-1868-2012	Packaging process control	Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Jul 2, 2010	Not classified	Z-2235-2010	Employee error	Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
11 of the 21 ancestors have a recall of any class.
Of its descendants, K091099 (Phs Medical GmbH, 2009) has gone furthest, with 5 descendants of its own.

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. 2007, 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 POWER INJECTABLE IMPLANTABLE INFUSION PORT IS INDICATED FOR PATIENT THERAPIES REQUIRING REPEATED ACCESS TO THE VASCULAR SYSTEM. THE PORT SYSTEM CAN BE USED FOR INFUSION OF MEDICATIONS, LV. FLUIDS, PARENTERAL NUTRITION SOLUTIONS, BLOOD PRODUCTS AND FOR THE WITHDRAWAL OF BLOOD SAMPLES.

WHEN USED WITH A POWER INJECTABLE NEEDLE, THE POWER INJECTABLE INFUSION PORT IS INDICATED FOR POWER INJECTION OF CONTRAST MEDIA. FOR POWER INJECTION OF CONTRAST MEDIA, THE MAXIMUM RECOMMENDED INFUSION RATE IS 5 ML/S WITH A 19 OR 20 GAUGE NON-CORING POWER INJECTABLE NEEDLE.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070003 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070003

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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