510(k) · Cleared
ClearedInfusor SV, Infusor LV, Baxter Pain Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Sep 5, 2000 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Sep 5, 2000
- Review
- 32 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK002380 Infusor SV, Infusor LV, Baxter Pain Management SystemBaxter Healthcare Corp · 2000
- Descendant · cites it directly · 5 of its ownK041738 Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)Baxter Healthcare Corporation · 2004
- Descendant · cites it directly · 4 of its ownK071222 Infusor SV and LV Elastomeric Infusion DevicesBaxter Healthcare Corp · 2007 · Recalled
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041738Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)Baxter Healthcare Corporation · 2004 · cites it directly5descendants
- K071222Infusor SV and LV Elastomeric Infusion DevicesBaxter Healthcare Corp · 2007 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002380 | Infusor SV, Infusor LV, Baxter Pain Management System | Baxter Healthcare Corp | 2000 | — |
| +1 | K041738 | Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume) | Baxter Healthcare Corporation | 2004 | — |
| +1 | K071222 | Infusor SV and LV Elastomeric Infusion Devices | Baxter Healthcare Corp | 2007 | 4 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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.
Planning a device in FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041738 (Baxter Healthcare Corporation, 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K002380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002380: Infusor SV, Infusor LV, Baxter Pain Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002380
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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