510(k) · Cleared
ClearedPort-a-Cath II Trans-Arterial Percutaneous System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Deltec, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Nov 18, 1999 as substantially equivalent to K942024 (Pharmacia Deltec, Inc., 1994) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 99 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830730 (1983). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830730 Port-a-Cath Implantable Cath. SysPharmacia, Inc. · 1983 · Recalled
- This deviceK992697 Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK033686 Port-a-Cath II Regional Arterial Portal SystemSmiths Medical MD, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · cites it directly1descendant
- K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · 2 generations on0descendants
- K033686Port-a-Cath II Regional Arterial Portal SystemSmiths Medical MD, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830730 | Port-a-Cath Implantable Cath. Sys | Pharmacia, Inc. | 1983 | 1 |
| 0 (this device) | K992697 | Port-a-Cath II Trans-Arterial Percutaneous System | Sims Deltec, Inc. | 1999 | — |
| +1 | K061424 | Celsite/ Celsite Concept, Access Ports | Aesculap, Inc. | 2006 | 2 |
| +2 | K130576 | Celsite Implantable Access Port Systems | B. Braun Interventional Systems, Inc. | 2013 | 2 |
| +1 | K033686 | Port-a-Cath II Regional Arterial Portal System | Smiths Medical MD, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K942024 | Port-a-Cath Low Profile Implantable Venous Access SystemSummary page 2…ystem PORT-A-CATH® II Low Profile™ System PORT-A-CATH® Arterial System MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K942024 K830730B INDICATIONS FOR A system is indicated A system is indicated A system is indicated USE when a patient requires when a pat… | 1994 |
| * | K830730 | Port-a-Cath Implantable Cath. SysSummary page 2…ORT-A-CATH® II Low Profile™ System PORT-A-CATH® Arterial System MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K942024 K830730B INDICATIONS FOR A system is indicated A system is indicated A system is indicated USE when a patient requires when a patient req… | 1983 |
What descends from it? (3)
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?
A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992697: Port-a-Cath II Trans-Arterial Percutaneous System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992697
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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