# K971067: Digi-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instrument Development Laboratories, Inc.
- Decided: Sep 19, 1997 after 179 days
- Product code: MRH (Pump, Infusion, Ophthalmic)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.

Source page: https://510kreport.com/device/K971067
Methodology: https://510kreport.com/methodology