510(k) · Cleared
ClearedLifeCare PCA Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · MEA Pump, Infusion, Pca
Cleared on Apr 8, 2016 as substantially equivalent to K043256 (Hospira, Inc., 2004) and 1 other predicate after a 476-day review. Its family tree reaches back 5 generations to 2001. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 8, 2016
- Review
- 476 days
- Class
- Class II
- Product code
- MEA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011442 (2001). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 4 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 3 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 2 generations backK042800 Lifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2004 · Recalled
- 1 generation backK043256 Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca…Hospira, Inc. · 2004 · Recalled
- This deviceK143612 LifeCare PCA Infusion SystemHospira, Inc. · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −4 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −3 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −2 | K042800 | Lifecare Pca Infusion System with Hospira Mednet Software | Hospira, Inc. | 2004 | 5 |
| −1 | K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion… | Hospira, Inc. | 2004 | 4 |
| 0 (this device) | K143612 | LifeCare PCA Infusion System | Hospira, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…Summary page 4…A) Infusion Pump FPA - Administration Sets Legally marketed device(s) to which Hospira LifeCare™ PCA3 Infusion System, cleared under K043256 equivalence is claimed Hospira LifeCare PCA™ Infusion Pump System with Hospira MedN… | 2004 |
| * | K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareSummary page 4…under K043256 equivalence is claimed Hospira LifeCare PCA™ Infusion Pump System with Hospira MedNet™ Software cleared under K042800 No Reference Devices were used in this submission P… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143612: LifeCare PCA Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143612
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026