510(k) · Cleared
ClearedDignity Power Injectable Titanium Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Sep 17, 2012 as substantially equivalent to K070003 (Medcomp, 2007) and 2 other predicates after a 230-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Sep 17, 2012
- Review
- 230 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K001901 (2000). 29 ancestors in all, the oldest K830000 (1983). No later device cites it as a predicate yet.
- 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 backK091099 C-Port - HP Power Injectable PortPhs Medical GmbH · 2009
- This deviceK120281 Dignity Power Injectable Titanium PortMedical Components, Inc. · 2012
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 backK091099 C-Port - HP Power Injectable PortPhs Medical GmbH · 2009
- This deviceK120281 Dignity Power Injectable Titanium PortMedical Components, Inc. · 2012
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 | K091099 | C-Port - HP Power Injectable Port | Phs Medical GmbH | 2009 | — |
| 0 (this device) | K120281 | Dignity Power Injectable Titanium Port | Medical Components, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Summary page 1…Catheter, Long-Term Greater than 30 Days CFR Reference: 21 CFR 880.5965, Class 11 Classification Panel: General Hospital Premarket Notification: K070003, Medcomp, Inc, concurrence date May 15, 2007 Device Trade Name: CT Power Injectable Implantable Port Common Name:… | 2007 |
| * | K111424 | Vacuette Premium Safety Needle System Tube-TouchSummary page 1…Catheter, Long-Term Greater than 30 Days CFR Reference: 21 CFR 880.5965, Class 11 Classification Panel: General Hospital Premarket Notification: 111424, Medcomp, Inc, concurrence date November 30, 2011 Device Trade Name: C-Port HP"Power Injectable" Port Common Name:… | 2011 |
| * | K091099 | C-Port - HP Power Injectable PortSummary page 1…Catheter, Long-Term Greater than 30 Days CFR Reference: 21 CFR 880.5965, Class 11 Classification Panel: General Hospital Premarket Notification: K091099, PHS Medical GmnbH Intended Use: Medcomp DignityO Power Injectable Titanium Port 510(k) Summary Page 1 of 2… | 2009 |
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?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 12 of the 29 ancestors have a recall of any class.
- 7 other devices also cite its predicate K070003.
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. 2012, 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 CT 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, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the Power Injectable Implantable Infusion Port device 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. The maximum recommended infusion rate is 2 mL/s with a 22 gauge non-coring power injectable needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120281: Dignity Power Injectable Titanium Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120281
Report an extraction error
Are you the manufacturer?
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