510(k) · Cleared
ClearedDib Infusor-RA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novacon Corp. · MEB Pump, Infusion, Elastomeric
Cleared on Aug 5, 1996 after a 195-day review. The FDA summary names no predicate by number. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Aug 5, 1996
- Review
- 195 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK960318 Dib Infusor-RANovacon Corp. · 1996
- Descendant · cites it directly · 8 of its ownK020251 Paragon Infusion SystemI-Flow Corp. · 2002
- Descendant · 2 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · 3 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 5 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump3 generations on · 2008
Most influential descendants
Showing 5 of 9 · See all- K020251Paragon Infusion SystemI-Flow Corp. · 2002 · cites it directly8descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 2 generations on5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 4 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960318 | Dib Infusor-RA | Novacon Corp. | 1996 | — |
| +1 | K020251 | Paragon Infusion System | I-Flow Corp. | 2002 | — |
| +2 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +3 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +4 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +5 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2005 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020251 | Paragon Infusion System | 2002 | 8 |
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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020251 (I-Flow Corp., 2002) has gone furthest, with 8 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?
The intended use of the DIB-RA Infusor is similar to that of other legally marketed elastomeric infusion pumps.
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/K960318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960318: Dib Infusor-RA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960318
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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