510(k) · Cleared
Recalled · Class II · 2014Modification to Plum XL Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FRN Pump, Infusion
Cleared on Apr 6, 2001 after a 10-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 6, 2001
- Review
- 10 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 6
- Predicates
- 0
14 later devices descend from it, 1 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- This deviceK010924 Modification to Plum XL Infusion PumpAbbott Laboratories · 2001
- Descendant · cites it directly · 13 of its ownK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK030136 Drip AlertDrip Alert, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK090087 Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Recalled (Class I)
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…cites it directly · 2001
- K090087 Mridium 3860 Mri Infusion Pump/Monitoring System2 generations on · 2009
- K133532 Alaris System with Guardrails Suite MX2 generations on · 2014
- K211218 BD Alaris System with Guardrails Suite MX v12.1.23 generations on · 2023
Most influential descendants
Showing 5 of 14 · See all- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…Alaris Medical Systems, Inc. · 2001 · cites it directly13descendants
- K050301Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · 2 generations on4descendants
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 2 generations on3descendants
- K030136Drip AlertDrip Alert, Inc. · 2003 · 2 generations on3descendants
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010924 | Modification to Plum XL Infusion Pump | Abbott Laboratories | 2001 | — |
| +1 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| +2 | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | 2 |
| +2 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| +2 | K030136 | Drip Alert | Drip Alert, Inc. | 2003 | — |
| +2 | K090087 | Mridium 3860 Mri Infusion Pump/Monitoring System | Iradimed Corporation | 2009 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 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.
4 devices in this family have 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii… Class I | 2001 | 13 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2014 | Class II | Z-1703-2014 | Component design/selection | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right… |
| Feb 14, 2011 | Not classified | Z-1599-2011 | Labeling design | Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting. |
| Aug 11, 2009 | Not classified | Z-0034-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Aug 11, 2009 | Not classified | Z-0030-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Aug 11, 2009 | Not classified | Z-0029-1010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Aug 11, 2009 | Not classified | Z-0031-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 13 Class I recalls
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
What does this lineage say?
- Of its descendants, K012383 (Alaris Medical Systems, Inc., 2001) has gone furthest, with 13 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K010924 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010924: Modification to Plum XL Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010924
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026