PMA · Approved
Recalled · Class II · 2021Prometra Programmable Infusion Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infusyn Therapeutics, LLC · LKK Pump, Infusion, Implanted, Programmable
Approved on Feb 7, 2012 through premarket approval, which rests on the device’s own clinical evidence after a 1,397-day review. It has been recalled 13 times.
- Decided
- Feb 7, 2012
- Review
- 1,397 days
- Class
- Class III
- Product code
- LKK
- Recalls
- 13
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P080012 has 63 supplements since 2012: 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 |
|---|---|
| 2012 | 6 |
| 2013 | 9 |
| 2014 | 3 |
| 2015 | 8 |
| 2016 | 4 |
| 2017 | 9 |
| 2018 | 2 |
| 2019 | 9 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 3 |
| 2024 | 2 |
| 2025 | 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 LKK? 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 |
|---|---|---|---|---|
| May 26, 2021 | Class II | Z-1996-2021 | Error in labeling | Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted… |
| Dec 24, 2019 | Class II | Z-1125-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Dec 24, 2019 | Class II | Z-1123-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Dec 24, 2019 | Class II | Z-1121-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Dec 24, 2019 | Class II | Z-1120-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Dec 24, 2019 | Class II | Z-1124-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Dec 24, 2019 | Class II | Z-1122-2020 | Software change control | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with… |
| Mar 21, 2019 | Class II | Z-1713-2019 | Software change control | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician… |
| Mar 21, 2019 | Class II | Z-1712-2019 | Software change control | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician… |
| Mar 21, 2019 | Class II | Z-1714-2019 | Software change control | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician… |
| Mar 21, 2019 | Class II | Z-1716-2019 | Software change control | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician… |
| Mar 21, 2019 | Class II | Z-1715-2019 | Software change control | The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician… |
| May 22, 2017 | Class II | Z-2740-2017 | Under Investigation by firm | Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to… |
The 5 latest of 13 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. 2012, this device’s year, is highlighted.
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/P080012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P080012: Prometra 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/P080012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026