# K050107: Harvard 2 Syringe Pump, Model 2001-001

- Pathway: 510(k) (Special)
- Applicant: Harvard Clinical Technology
- Decided: Feb 11, 2005 after 24 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices 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 1 Syringe Pump: named in the summary without a submission number
- (no number) Harvard 2 Syringe Pump: named in the summary without a submission number

## Most influential descendants
- K053554: Compuflo (2006), 6 descendants of its own
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010 (2011), 5 descendants of its own
- K112067: Navigator Delivery System (Navigator DS) (2011), 4 descendants of its own
- K120830: Navigator Delivery System (Navigator DS) (2012), 3 descendants of its own
- K122215: Navigator Delivery System (Navigator DS) (2012), 2 descendants of its own

## Indications for use
The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when administered by health care professionals such as physicians and nurses.

Source page: https://510kreport.com/device/K050107
Methodology: https://510kreport.com/methodology