510(k) · Cleared
ClearedSMARTeZ™ Elastomeric Infusion Pump (RS series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Medical Pte., Ltd. · MEB Pump, Infusion, Elastomeric
Cleared on Apr 24, 2026 as substantially equivalent to K151650 (Epic Medical Pte., Ltd., 2016) after a 452-day review. Its family tree reaches back 12 generations to 1990. 1 of the 49 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 452 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896422 (1990). 48 ancestors in all, the oldest K802820 (1980). No later device cites it as a predicate yet. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 8 generations between
- 3 generations backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- 2 generations backK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- 1 generation backK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- This deviceK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 11 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 10 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 9 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 8 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 7 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 6 generations backK032642 Beeline SystemMckinley, Inc. · 2003
- 5 generations backK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- 4 generations backK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- 3 generations backK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- 2 generations backK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- 1 generation backK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- This deviceK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −11 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −10 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −9 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −8 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −7 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −6 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| −5 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| −4 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| −3 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| −2 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| −1 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| 0 (this device) | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 K240624 InfuLifescore 11.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K151650 | SMARTez elastomeric infusion pumpSummary page 5…ulation Name: Infusion Pump Regulatory Class: Class: II Product Code: MEB III. Predicate 510(k) Number: K151650 Trade/ Device Name: SMARTeZ™ Elastomeric Infusion Pump Common/ Usual Name: Pump, Infusion, Elastomeric… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K151650.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
• Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
• Routes of administration: intravenous and intra-arterial.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250234
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026