510(k) · Cleared
Recalled · 2006Port-a-Cath Implantable Vascular Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia Deltec, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jan 5, 1994 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 25 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 5, 1994
- Review
- 208 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 2
- Predicates
- 0
24 later devices descend from it, 5 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- This deviceK932840 Port-a-Cath Implantable Vascular Access SystemPharmacia Deltec, Inc. · 1994
- Descendant · cites it directly · 19 of its ownK962695 Port-a-Cath II Venous Implantable Access Systems Preconnected with…Sims Deltec, Inc. · 1996 · Recalled
- Descendant · cites it directly · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K994216 Plastic Port Implantable Venous Access Systemcites it directly · 2000
Most influential descendants
Showing 5 of 24 · See all- K962695Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane CatheterSims Deltec, Inc. · 1996 · cites it directly19descendants
- K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · cites it directly18descendants
- K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
- K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
- K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932840 | Port-a-Cath Implantable Vascular Access System | Pharmacia Deltec, Inc. | 1994 | — |
| +1 | K962695 | Port-a-Cath II Venous Implantable Access Systems Preconnected with… | Sims Deltec, Inc. | 1996 | 6 |
| +1 | K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems… | Smiths Medical MD, Inc. | 2007 | — |
| +2 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| +3 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… | B.Braun Medical, Inc. | 2017 | — |
| +4 | K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (24)
See all 245 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962695 | Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter | 1996 | 19 |
| K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power… | 2007 | 18 |
| K061424 | Celsite/ Celsite Concept, Access Ports | 2006 | 1 |
| K033686 | Port-a-Cath II Regional Arterial Portal System | 2004 | 0 |
| K994216 | Plastic Port Implantable Venous Access System Class I | 2000 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2006 | Not classified | Z-0800-06 | Other | One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed… |
| Mar 29, 2004 | Not classified | Z-0865-04 | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. |
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, K962695 (Sims Deltec, Inc., 1996) has gone furthest, with 19 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/K932840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932840: Port-a-Cath Implantable Vascular Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932840
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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