510(k) · Cleared
Recalled · 2011Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5 ML/HR (Elastomeric Infusion Device) Model CY
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 Sep 4, 1998 after an 81-day review. The FDA summary names its predicate without a number. 1 of the 7 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 4, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- This deviceK982102 Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model…Baxter Healthcare Corp · 1998
- Descendant · cites it directly · 5 of its ownK062457 Infusor Small Volume Elastomeric Infusion DevicesBaxter Healthcare Corporation · 2006 · Recalled
- Descendant · 2 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 4 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations on · 2008
Most influential descendants
Showing 5 of 6 · See all- K062457Infusor Small Volume Elastomeric Infusion DevicesBaxter Healthcare Corporation · 2006 · cites it directly5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 3 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 4 generations on0descendants
- K240624InfuLifeFirst Medical Source, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982102 | Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5… | Baxter Healthcare Corp | 1998 | — |
| +1 | K062457 | Infusor Small Volume Elastomeric Infusion Devices | Baxter Healthcare Corporation | 2006 | 2 |
| +2 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +3 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +4 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
| +4 | K240624 | InfuLife | First Medical Source, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | — | Singleday Infusor Named without a submission number | |
| * | — | Multiday Infusor Named without a submission number | |
| * | — | Infusor SV Named without a submission number | |
| * | — | Seven Day Infusor Named without a submission number | |
| * | — | 2 Day Infusor Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062457 | Infusor Small Volume Elastomeric Infusion Devices | 2006 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2011 | Not classified | Z-2146-2011 | Labeling mix-ups | Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054. |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062457 (Baxter Healthcare Corporation, 2006) has gone furthest, with 5 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982102: Singleday Infusor 2 ML/HR (Elastomeric Infusion Device) Model, Infusor SV 5 ML/HR (Elastomeric Infusion Device) Model CY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982102
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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