# K033054: Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe Pump

- Pathway: 510(k) (Traditional)
- Applicant: Harvard Clinical Technology
- Decided: Dec 16, 2003 after 78 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Harvard 2 Syringe Pump: named in the summary without a submission number
- (no number) Medex Protégé: named in the summary without a submission number
- (no number) B. Braun Horizon with Dose Scan: named in the summary without a submission number
- (no number) Baxter PCA-II: named in the summary without a submission number

## Recalls of this device
- Nov 3, 2004 · Not classified · Z-0433-05: Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- Nov 3, 2004 · Not classified · Z-0432-05: Potential pump motor/encoder assembly failure may cause over infusing medication in patients

## Indications for use
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.

Source page: https://510kreport.com/device/K033054
Methodology: https://510kreport.com/methodology