510(k) · Cleared
ClearedX-Prot Duo Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jul 10, 2003 as substantially equivalent to K912702 (Davol, Inc., 1991) after an 8-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jul 10, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912702 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912702 Plastic Attachable Dual PortDavol, Inc. · 1991
- This deviceK032044 X-Prot Duo PortC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK133335 Powerport Implantable PortC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK034065 Modification to X-Port Duo PortC.R. Bard, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912702 | Plastic Attachable Dual Port | Davol, Inc. | 1991 | — |
| 0 (this device) | K032044 | X-Prot Duo Port | C.R. Bard, Inc. | 2003 | — |
| +1 | K133335 | Powerport Implantable Port | C.R. Bard, Inc. | 2014 | — |
| +1 | K034065 | Modification to X-Port Duo Port | C.R. Bard, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K912702 | Plastic Attachable Dual PortSummary page 1…21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Port and Catheter, Class I1 Premarket Notification: K912702, concurrence date - 18 September 1991. 6.4 Device Description Principles of Operation There are no new operating… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 BardPort®, SlimPort™ and X-Port™ Implanted Ports are 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032044: X-Prot Duo Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032044
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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