510(k) · Cleared
ClearedExtension Set W/Flow Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Jun 8, 1989 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jun 8, 1989
- Review
- 128 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK890489 Extension Set W/Flow RegulatorBaxter Healthcare Corp · 1989
- 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 10 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 10 · 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) | K890489 | Extension Set W/Flow Regulator | Baxter Healthcare Corp | 1989 | — |
| +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 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
https://510kreport.com/device/K890489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K890489: Extension Set W/Flow Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890489
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026