510(k) · Cleared
Recalled · 2004Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvard Clinical Technology · MEA Pump, Infusion, Pca
Cleared on Dec 16, 2003 after a 78-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Dec 16, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 2
- 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? (4)
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 |
|---|---|---|---|
| * | — | Harvard 2 Syringe Pump Named without a submission number | |
| * | — | Medex Protégé Named without a submission number | |
| * | — | B. Braun Horizon with Dose Scan Named without a submission number | |
| * | — | Baxter PCA-II 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 |
|---|---|---|---|---|
| Nov 3, 2004 | Not classified | Z-0433-05 | Other | Potential pump motor/encoder assembly failure may cause over infusing medication in patients |
| Nov 3, 2004 | Not classified | Z-0432-05 | Other | Potential pump motor/encoder assembly failure may cause over infusing medication in patients |
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?
Harvard I The Harvard I is designed to provide, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less. Harvard 1with PCA Harvard 1 with PCA is designed provide patient controlled…
Read the full statement (130 words)
Harvard I
The Harvard I is designed to provide, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses.
The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less.
Harvard 1with PCA
Harvard 1 with PCA is designed provide patient controlled analgesia, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products, or other parenteral fluids when administered by a health care professionals such as physicians and nurses.
The Harvard 1 with PCA is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033054: Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033054
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026