510(k) · Cleared
ClearedPort-a-Cath Vascular Access Systems
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 Mar 31, 1987 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Mar 31, 1987
- Review
- 139 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK864446 Port-a-Cath Vascular Access SystemsPharmacia, Inc. · 1987
- 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
- Descendant · 4 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- 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
- K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864446 | Port-a-Cath Vascular Access Systems | Pharmacia, Inc. | 1987 | — |
| +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 | — |
| +4 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power… | 2007 | 18 |
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?
- Of its descendants, K070116 (Smiths Medical MD, Inc., 2007) has gone furthest, with 18 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/K864446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K864446: Port-a-Cath Vascular Access Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864446
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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