510(k) · Cleared
ClearedIpump Pain Management System, Model 2L3107, 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 Jan 25, 2007 as substantially equivalent to K993387 (Baxter Healthcare Corp, 1999) after a 458-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 458 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926385 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK926385 Bard Apii PumpC.R. Bard, Inc. · 1994 · Recalled
- 1 generation backK993387 Ipump Pain Management System, Model 2L3107KBaxter Healthcare Corp · 1999 · Recalled
- This deviceK052973 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926385 | Bard Apii Pump | C.R. Bard, Inc. | 1994 | 2 |
| −1 | K993387 | Ipump Pain Management System, Model 2L3107K | Baxter Healthcare Corp | 1999 | 3 |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K993387 | Ipump Pain Management System, Model 2L3107KSummary page 1…External Infusion Pump Classification name Infusion Pump (21 CFR 880.5725, Product Code 80 FRN) Predicate Device IpumpTM Pain Management System, K993387 cleared on 01 November 1999 Baxter Confidential… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120209 | Patient Controlled Analgesia (Pca) Button Cable | 2012 | 1 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K120209 (American I.V. Products, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K993387.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 TM Pain Management system is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional (local) analgesia applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052973: Ipump Pain Management System, Model 2L3107, 2L3107K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052973
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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