PMA · Approved
Recalled · Class I · 2026Medstream Programmable Infusion Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intera Oncology · LKK Pump, Infusion, Implanted, Programmable
Approved on Mar 11, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 2,356-day review. It has a Class I recall. It has been recalled 15 times, including 11 Class I recalls.
- Decided
- Mar 11, 1996
- Review
- 2,356 days
- Class
- Class III
- Product code
- LKK
- Recalls
- 15 (11 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P890055 has 86 supplements since 1996: 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 |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 6 |
| 2012 | 8 |
| 2013 | 5 |
| 2014 | 7 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 4 |
| 2018 | 3 |
| 2020 | 2 |
| 2021 | 4 |
| 2022 | 5 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 2 |
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.
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.
- 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2026 | Class II | Z-2580-2026 | Process control | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| Jul 10, 2022 | Class I | Z-1522-2022 | Process design | Higher than expected flow rate. |
| Nov 10, 2015 | Class II | Z-1571-2014 | Device Design | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. |
| Nov 10, 2015 | Class II | Z-1572-2014 | Device Design | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. |
| Mar 5, 2015 | Class II | Z-1684-2015 | Process control | Needle is leaking from hub/needle cannula connection |
| Aug 13, 2013 | Class I | Z-2300-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2295-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2296-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2299-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2297-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2298-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2293-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Aug 13, 2013 | Class I | Z-2294-2013 | Use error | Drug flow rates exceeding programmed flow rates. |
| Jun 7, 2013 | Class I | Z-1690-2013 | Device Design | Miscalibrated Fill Level Sensor may affect dosing level |
| Jun 7, 2013 | Class I | Z-1691-2013 | Device Design | Miscalibrated Fill Level Sensor may affect dosing level |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LKK devicesLKK Pump, Infusion, Implanted, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKK
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKK
Too few LKK 510(k)s in any year since 2007 to give a median.
Recalls per year · LKK
5in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · LKK
5,732in 2025
MAUDE reports naming product code LKK, 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 | 8 | — | 16 | 2,676 |
| 2008 | 8 | — | 35 | 3,398 |
| 2009 | 10 | — | 6 | 3,225 |
| 2010 | 29 | — | 2 | 4,067 |
| 2011 | 34 | — | 4 | 3,913 |
| 2012 | 33 | — | 3 (2) | 5,557 |
| 2013 | 33 | — | 0 | 8,055 |
| 2014 | 28 | — | 0 | 7,458 |
| 2015 | 40 | — | 0 | 8,451 |
| 2016 | 30 | — | 1 (1) | 8,461 |
| 2017 | 42 | — | 2 | 7,751 |
| 2018 | 55 | — | 0 | 6,936 |
| 2019 | 57 | — | 1 (1) | 5,652 |
| 2020 | 49 | — | 1 | 5,115 |
| 2021 | 32 | — | 0 | 4,713 |
| 2022 | 32 | — | 0 | 4,310 |
| 2023 | 19 | — | 2 | 4,041 |
| 2024 | 22 | — | 5 | 4,618 |
| 2025 | 22 | — | 0 | 5,732 |
| 2026 | 9 | — | 2 | — |
https://510kreport.com/device/P890055 · printed Nov 6, 2026
Cite this page
510(k) Report. “P890055: Medstream Programmable Infusion Pump System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P890055
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026