510(k) · Cleared
Recalled · Class II · 2013Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MEB Pump, Infusion, Elastomeric
Cleared on Jun 28, 2001 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 28, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK011317 Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain…Baxter Healthcare Corp · 2001
- 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
- Descendant · cites it directly · 0 of its ownK051828 Nipro Surefuser Ambulatory Infusion PumpNipro Medical Corporation · 2005
Most influential descendants
Showing 4 of 4 · 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
- K051828Nipro Surefuser Ambulatory Infusion PumpNipro Medical Corporation · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011317 | Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management… | Baxter Healthcare Corp | 2001 | — |
| +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 | — |
| +1 | K051828 | Nipro Surefuser Ambulatory Infusion Pump | Nipro Medical Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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 MEB? 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jun 7, 2013 | Class II | Z-1601-2013 | 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?
- Of its descendants, K051253 (Baxter Healthcare Corp, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K011317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011317: Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011317
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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