# K962709: Sigma Syringe Delivery System (Multi-Doser Rev. 1/Multi-Doser Rev. II/Single-Doser Rev. 1-10/Single-Doser Rev. 1-20/

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Intl.
- Decided: Oct 7, 1996 after 87 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.
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) Medifuse™ from 3M: named in the summary without a submission number
- (no number) Band-It from I-Flow®: named in the summary without a submission number
- (no number) Side-Kick™ from I-Flow®: named in the summary without a submission number

## Indications for use
The “Sigma Syringe Delivery System” is designed for the controlied intermittent administration of small volume intravenous fluid medications for the treatment of human or animal subjects. Its specific design characteristics limit the device’s use to slow, non-rate critical, small volume parenteral applications, identical to the predicate devices.

Source page: https://510kreport.com/device/K962709
Methodology: https://510kreport.com/methodology