510(k) · Cleared
Recalled · 2005Ipump Pain Management System, Model 2L3107K
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 Nov 1, 1999 as substantially equivalent to K926385 (C.R. Bard, Inc., 1994) after a 24-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 1, 1999
- Review
- 24 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926385 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK926385 Bard Apii PumpC.R. Bard, Inc. · 1994 · Recalled
- This deviceK993387 Ipump Pain Management System, Model 2L3107KBaxter Healthcare Corp · 1999
- Descendant · cites it directly · 2 of its ownK052973 Ipump Pain Management System, Model 2L3107, 2L3107KBaxter Healthcare Corp · 2007
- Descendant · cites it directly · 1 of its ownK120209 Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK220695 Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022
Most influential descendants
Showing 3 of 3 · See all- K052973Ipump Pain Management System, Model 2L3107, 2L3107KBaxter Healthcare Corp · 2007 · cites it directly2descendants
- K120209Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012 · cites it directly1descendant
- K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926385 | Bard Apii Pump | C.R. Bard, Inc. | 1994 | 2 |
| 0 (this device) | K993387 | Ipump Pain Management System, Model 2L3107K | Baxter Healthcare Corp | 1999 | — |
| +1 | K052973 | Ipump Pain Management System, Model 2L3107, 2L3107K | Baxter Healthcare Corp | 2007 | — |
| +1 | K120209 | Patient Controlled Analgesia (Pca) Button Cable | American I.V. Products, Inc. | 2012 | — |
| +2 | K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K926385 | Bard Apii PumpSummary page 1…e Corporation 1.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073 Proposed Device: Ipump™ Pain Management System Predicate Device: APII Infusion Pump, K926385, cleared 4/18/1994 Device Description and Statement of Intended Use: The Ipump™ Pain Management System is an electronic infusio… | 1994 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2005 | Not classified | Z-0551-06 | Other | Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button. |
| Oct 27, 2005 | Not classified | Z-0549-06 | Other | When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion. |
| Feb 10, 2005 | Not classified | Z-0130-06 | Other | Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K052973 (Baxter Healthcare Corp, 2007) has gone furthest, with 2 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) | — |
What is it indicated for?
The Ipump™ Pain Management System is indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.
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/K993387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993387: Ipump Pain Management System, Model 2L3107K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993387
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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