# K971168: One-Day/Five-Day/Seven-Day Syringe Mate

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 15, 1997 after 106 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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.
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) Uni*Dose Infusion Pump: named in the summary without a submission number
- (no number) Baxter Multiday Infusor: named in the summary without a submission number

## Indications for use
The Syringe*Mate System is indicated for patients requiring slow, continuous intravenous, epidural, or subcutaneous administration of medications.

Source page: https://510kreport.com/device/K971168
Methodology: https://510kreport.com/methodology