510(k) · Cleared
ClearedModification to: T-Port HP Infusion Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 12, 2007 as substantially equivalent to K071993 (Pfm Medical, Inc., 2007) after a 28-day review. Its family tree reaches back 9 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 12, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 24 ancestors in all, the oldest K863606 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 1 generation backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- This deviceK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 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
- Descendant · 2 generations on · 0 of its ownK153228 NMI Port, NMI Port IINavilyst Medical, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 1 generation backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- This deviceK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
Most influential descendants
Showing 4 of 4 · See all- 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
- K153228NMI Port, NMI Port IINavilyst Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −2 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| −1 | K071993 | T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| 0 (this device) | K073210 | Modification to: T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| +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 | — |
| +2 | K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K071993 | T-Port HP Infusion PortSummary page 1…ular Classification Name: Same Equivalent Devices: Manufacturer: PFM Medical, Inc Name: T-Port HP Infusion Port 51 0(k)# K071993 Device Description: The T-Port HP Infusion Port is an implantable device designed to provide repeated access to the vascular sy… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122767 | Nmi Port | 2013 | 3 |
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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 13 of the 24 ancestors have a recall of any class.
- Of its descendants, K122767 (Navilyst Medical, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071993.
How does its category compare?
All LJT devicesLJT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 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 T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IVfluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073210 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073210: Modification to: T-Port HP Infusion Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073210
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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