510(k) · Cleared
ClearedBaxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · FRN Pump, Infusion
Cleared on Jul 9, 2004 as substantially equivalent to K002380 (Baxter Healthcare Corp, 2000) after an 11-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jul 9, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002380 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002380 Infusor SV, Infusor LV, Baxter Pain Management SystemBaxter Healthcare Corp · 2000
- This deviceK041738 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
- Descendant · 3 generations on · 0 of its ownK242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- 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
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002380 | Infusor SV, Infusor LV, Baxter Pain Management System | Baxter Healthcare Corp | 2000 | — |
| 0 (this device) | 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 | — |
| +3 | K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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.
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? (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 |
|---|---|---|---|
| * | K002380 | Infusor SV, Infusor LV, Baxter Pain Management SystemSummary page 1…ve pain management. This is consistent with the intended use for the Jnfiisor SV and Infusor LV devices as cleared under premarket notification K0023 80. Technological Characteristics: A modified design is being added to Baxter's Infusor line of Elastomeric… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071222 | Infusor SV and LV Elastomeric Infusion Devices | 2007 | 4 |
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?
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) | — |
What is it indicated for?
The modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041738: Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041738
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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