510(k) · Cleared
ClearedFLEXI-PORT™ Power Injectable Implantable Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portal Access, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jun 17, 2026 as substantially equivalent to K242328 (Bard Access Systems, Inc., 2024) after a 90-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Jun 17, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 23 ancestors in all, the oldest K863606 (1986). 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 backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™…Bard Access Systems, Inc. · 2024
- This deviceK260916 FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
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 backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™…Bard Access Systems, Inc. · 2024
- This deviceK260916 FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
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 | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | C.R. Bard, Inc. | 2007 | 7 |
| −1 | K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim… | Bard Access Systems, Inc. | 2024 | — |
| 0 (this device) | K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Summary page 5…s, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Classification Panel: General Hospital Product Code: LJT Predicate Device 510(k) Number: K242328 Trade Name: Bard Access Systems, Inc., PowerPort™ ClearVUE™ Slim Implantable Port Common or Usual Name: Subcutaneous Implanted In… | 2024 |
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 26 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 13 of the 23 ancestors have a recall of any class.
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. 2026, 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 FLEXI-PORT Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples.
When used with a power injectable needle, the FLEXI-PORT is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260916: FLEXI-PORT™ Power Injectable 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/K260916
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026