510(k) · Cleared
Recalled · 2005Syndeo Pca Syringe Pump, Model 2L3113
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MEA Pump, Infusion, Pca
Cleared on Aug 19, 2003 after a 92-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Aug 19, 2003
- Review
- 92 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | PCA II Syringe Infusion Pump Named without a submission number | |
| * | — | iPump Pain Management System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2005 | Not classified | Z-1373-05 | Device Design | During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Syndeo PCA Syringe Pump is designed 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, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031566: Syndeo Pca Syringe Pump, Model 2L3113.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031566
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026