510(k) · Cleared
Recalled · Class II · 2015Port-a-Cath Implantable Cath. Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jun 30, 1983 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 1983
- Review
- 114 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK830730 Port-a-Cath Implantable Cath. SysPharmacia, Inc. · 1983
- Descendant · cites it directly · 3 of its ownK992697 Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK033686 Port-a-Cath II Regional Arterial Portal SystemSmiths Medical MD, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK994216 Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 2000 · Recalled (Class I)
Class I recalls in this family
- K994216 Plastic Port Implantable Venous Access Systemcites it directly · 2000
Most influential descendants
Showing 5 of 5 · See all- K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999 · cites it directly3descendants
- K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · 2 generations on1descendant
- K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · 3 generations on0descendants
- K033686Port-a-Cath II Regional Arterial Portal SystemSmiths Medical MD, Inc. · 2004 · 2 generations on0descendants
- K994216Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830730 | Port-a-Cath Implantable Cath. Sys | Pharmacia, Inc. | 1983 | — |
| +1 | K992697 | Port-a-Cath II Trans-Arterial Percutaneous System | Sims Deltec, Inc. | 1999 | — |
| +2 | K061424 | Celsite/ Celsite Concept, Access Ports | Aesculap, Inc. | 2006 | 2 |
| +3 | K130576 | Celsite Implantable Access Port Systems | B. Braun Interventional Systems, Inc. | 2013 | 2 |
| +2 | K033686 | Port-a-Cath II Regional Arterial Portal System | Smiths Medical MD, Inc. | 2004 | — |
| +1 | K994216 | Plastic Port Implantable Venous Access System | Sims Deltec, Inc. | 2000 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2015 | Class II | Z-0152-2016 | Labeling mix-ups | The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K994216Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- Of its descendants, K992697 (Sims Deltec, Inc., 1999) has gone furthest, with 3 descendants of its own.
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) | — |
https://510kreport.com/device/K830730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K830730: Port-a-Cath Implantable Cath. Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K830730
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026