PMA · Approved
Recalled · 2004Port-a-Cath (R) Epidural Implantable Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · LNY Catheter, Percutaneous, Long Term, Intraspinal
Approved on Apr 22, 1991 through premarket approval, which rests on the device’s own clinical evidence after a 277-day review. It has been recalled 2 times.
- Decided
- Apr 22, 1991
- Review
- 277 days
- Class
- Class III
- Product code
- LNY
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P900052 has 17 supplements since 1995: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 3 |
| 2007 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2004 | Not classified | Z-0856-04 | 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. |
| Mar 29, 2004 | Not classified | Z-0857-04 | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LNY devicesLNY Catheter, Percutaneous, Long Term, Intraspinal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LNY
Too few LNY 510(k)s in any year since 2007 to give a median.
Recalls per year · LNY
No recall names LNY since 2007.
Adverse event reports per year · LNY
1in 2025
MAUDE reports naming product code LNY, 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 | 3 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P900052 · printed Nov 6, 2026
Cite this page
510(k) Report. “P900052: Port-a-Cath (R) Epidural Implantable Access System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900052
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026