510(k) · Cleared
Recalled · Class II · 2013Infusor SV and LV Elastomeric Infusion Devices
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 May 25, 2007 as substantially equivalent to K041738 (Baxter Healthcare Corporation, 2004) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- May 25, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002380 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002380 Infusor SV, Infusor LV, Baxter Pain Management SystemBaxter Healthcare Corp · 2000
- 1 generation backK041738 Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)Baxter Healthcare Corporation · 2004
- This deviceK071222 Infusor SV and LV Elastomeric Infusion DevicesBaxter Healthcare Corp · 2007
- Descendant · cites it directly · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · cites it directly3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 2 generations on0descendants
- K240624InfuLifeFirst Medical Source, LLC · 2024 · 2 generations on0descendants
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002380 | Infusor SV, Infusor LV, Baxter Pain Management System | Baxter Healthcare Corp | 2000 | — |
| −1 | K041738 | Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume) | Baxter Healthcare Corporation | 2004 | — |
| 0 (this device) | K071222 | Infusor SV and LV Elastomeric Infusion Devices | Baxter Healthcare Corp | 2007 | — |
| +1 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +2 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +2 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
| +2 | K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K041738 | Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)Summary page 2…Previous 510(k)s Device Previous 5 10(k) Clearance date Baxter SV/LV Infusor K041738 July 9, 2004 Elastomeric Infusion Device Baxter Pain Management Infusor K002380 Sept… | 2004 |
| * | K002380 | Infusor SV, Infusor LV, Baxter Pain Management SystemSummary page 2…0(k) Clearance date Baxter SV/LV Infusor K041738 July 9, 2004 Elastomeric Infusion Device Baxter Pain Management Infusor K002380 September 5, 2000 Elastomeric Infusion Device DESCRIPTION OF THE DEVICE AND MODIFICATION: Baxter's Infus… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151650 | SMARTez elastomeric infusion pump | 2016 | 3 |
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-1600-2013 | 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… |
| Jul 31, 2009 | Class II | Z-1679-2013 | Equipment maintenance | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps… |
| Jul 31, 2009 | Class II | Z-1677-2013 | Equipment maintenance | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps… |
| Jul 31, 2009 | Class II | Z-1678-2013 | Equipment maintenance | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151650 (Epic Medical Pte., Ltd., 2016) has gone furthest, with 3 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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Infusion Pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071222: Infusor SV and LV Elastomeric Infusion Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071222
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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