510(k) · Cleared
Recalled · Class II · 2019Bardport X-Port Isp 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 Sep 25, 2002 as substantially equivalent to K873213 (C.R. Bard, Inc., 1987) after a 16-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873213 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK873213 Hickman Plastic Subcutaneous PortC.R. Bard, Inc. · 1987 · Recalled
- This deviceK022983 Bardport X-Port Isp PortC.R. Bard, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK153359 BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK133335 Powerport Implantable PortC.R. Bard, Inc. · 2014
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 | K873213 | Hickman Plastic Subcutaneous Port | C.R. Bard, Inc. | 1987 | 3 |
| 0 (this device) | K022983 | Bardport X-Port Isp Port | C.R. Bard, Inc. | 2002 | — |
| +1 | K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | 2016 | — |
| +1 | K133335 | Powerport Implantable Port | C.R. Bard, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K873213 | Hickman Plastic Subcutaneous PortSummary page 1…2 1 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Port and Catheter, Class I1 Premarket Notification: K873213, concurrence date - October 27, 1987. 6.4 Device Description Principles of Operation There are no new operating… | 1987 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2019 | Class II | Z-1578-2020 | Component change control | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation. |
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® and SlimPort™ 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/K022983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022983: Bardport X-Port Isp Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022983
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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