510(k) · Cleared
Recalled · Class II · 2013Infusor Small Volume Elastomeric Infusion Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · MEB Pump, Infusion, Elastomeric
Cleared on Sep 21, 2006 as substantially equivalent to K802820 (Travenol Laboratories, S.A., 1980) and 6 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1980. 1 of the 13 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 21, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 1 generation to K802820 (1980). 7 ancestors in all. 5 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK802820 Travenol 24 HR. Infusor (Elastomeric PP)Travenol Laboratories, S.A. · 1980
- This deviceK062457 Infusor Small Volume Elastomeric Infusion DevicesBaxter Healthcare Corporation · 2006
- Descendant · cites it directly · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pumpcites it directly · 2008
Most influential descendants
Showing 5 of 5 · See all- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · cites it directly4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 2 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 3 generations on0descendants
- K240624InfuLifeFirst Medical Source, LLC · 2024 · 3 generations on0descendants
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802820 | Travenol 24 HR. Infusor (Elastomeric PP) | Travenol Laboratories, S.A. | 1980 | — |
| 0 (this device) | K062457 | Infusor Small Volume Elastomeric Infusion Devices | Baxter Healthcare Corporation | 2006 | — |
| +1 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +2 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +3 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +3 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
| +3 | K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | K802820 | Travenol 24 HR. Infusor (Elastomeric PP)Summary page 2…Previous 510(k)s Device Previous 510(k) Clearance date Single day Infusor K802820 November 7, 1980 K905778 July 12, 1991… | 1980 |
| * | K905778 | Epidural Indication for Baxter Infusors AttachmentSummary page 2…Previous 510(k) Clearance date Single day Infusor K802820 November 7, 1980 K905778 July 12, 1991 K982102 September 4, 1998 Half Day Infus… | 1991 |
| * | K982102 | Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5 ML/HR…Summary page 2…K802820 November 7, 1980 K905778 July 12, 1991 K982102 September 4, 1998 Half Day Infusor K853881 December 2, 1985… | 1998 |
| * | K853881 | The Travenol 5 ML/HR InfusorSummary page 2…K905778 July 12, 1991 K982102 September 4, 1998 Half Day Infusor K853881 December 2, 1985 K905778 July 12, 1991… | 1985 |
| * | K842479 | I.V. TeamateSummary page 2…K982102 September 4, 1998 2 Day Infusor K802820 November 7, 1980 K842479 November 2, 1984 K870242 March 13, 1987… | 1984 |
| * | K870242 | Intermate (TM)Summary page 2…K802820 November 7, 1980 K842479 November 2, 1984 K870242 March 13, 1987 K905778 July 12, 1991… | 1987 |
| * | K842905 | Travenol Multiday Infusor 2C1080Summary page 2…K905778 July 12, 1991 K982102 September 4, 1998 Multiday Infusor K842905 November 1, 1985 K905778 July 12, 1991… | 1985 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081905 | Accuflow and Accuflux Elastomeric Infusion Pump Class I | 2008 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2013 | Class II | Z-1609-2013 | Device Design | Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. |
| Nov 29, 2007 | Not classified | Z-0588-2008 | Process control | Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling. |
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.
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K081905 (Westmed, Inc., 2008) has gone furthest, with 4 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 | — |
What is it indicated for?
Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062457: Infusor Small Volume Elastomeric Infusion Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062457
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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