510(k) · Cleared
Recalled · Class II · 2014Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM)
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 Jul 15, 2005 as substantially equivalent to K011317 (Baxter Healthcare Corp, 2001) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 15, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002739 (2000). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002739 Infusor Patient Control Module, 2ML, Model 2C1067KBaxter Healthcare Corp · 2000
- This deviceK051253 Modification to: Multirate Infusor SV )with and Without PCM)…Baxter Healthcare Corp · 2005
- Descendant · cites it directly · 0 of its ownK131247 Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK060933 Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002739 | Infusor Patient Control Module, 2ML, Model 2C1067K | Baxter Healthcare Corp | 2000 | — |
| 0 (this device) | K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate… | Baxter Healthcare Corp | 2005 | — |
| +1 | K131247 | Multibolus II Disposable Pain Management System | Mfs - Medical Flow Systems, Ltd. | 2013 | — |
| +1 | K060933 | Solace Post-Operative Pain Relief Infusion System | Apex Medical Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K011317 | Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System | 2001 |
| * | K002739 | Infusor Patient Control Module, 2ML, Model 2C1067KSummary page 1…, as well as allow for intermittent bolus doses of medication on patient demand. The modifications made to the Multirate Infusor (KOI 1317) line to incorporate a PCM (K(002739) include the following: *Inserting the same PVC "Y" connector from the single rate Infusors (K(041738, K(884505) bef… | 2000 |
| † | K041738 | Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume) | 2004 |
| † | K884505 | Basal/Bolus Infusors | 1989 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2014 | Class II | Z-1536-2015 | Process control | Potential for device malfunction resulting in flow when the device should not be flowing |
| Jun 7, 2013 | Class II | Z-1602-2013 | Nonconforming Material/Component | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intra-operative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051253
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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