510(k) · Cleared
ClearedInfusor Patient Control Module, 2ML, Model 2C1067K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MEA Pump, Infusion, Pca
Cleared on Sep 11, 2000 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 11, 2000
- Review
- 10 days
- Class
- Class II
- Product code
- MEA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK002739 Infusor Patient Control Module, 2ML, Model 2C1067KBaxter Healthcare Corp · 2000
- Descendant · cites it directly · 2 of its ownK051253 Modification to: Multirate Infusor SV )with and Without PCM)…Baxter Healthcare Corp · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK131247 Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK060933 Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K051253Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…Baxter Healthcare Corp · 2005 · cites it directly2descendants
- K131247Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013 · 2 generations on0descendants
- K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002739 | Infusor Patient Control Module, 2ML, Model 2C1067K | Baxter Healthcare Corp | 2000 | — |
| +1 | K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate… | Baxter Healthcare Corp | 2005 | 2 |
| +2 | K131247 | Multibolus II Disposable Pain Management System | Mfs - Medical Flow Systems, Ltd. | 2013 | — |
| +2 | K060933 | Solace Post-Operative Pain Relief Infusion System | Apex Medical Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 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.
Planning a device in MEA? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with… | 2005 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051253 (Baxter Healthcare Corp, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002739: Infusor Patient Control Module, 2ML, Model 2C1067K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002739
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026