# K991225: Mti 1 ML Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jul 8, 1999 after 87 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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) Medallion Syringe: named in the summary without a submission number

## Indications for use
The MTI 1 ml Syringe is intended for injection and aspiration of fluids. The syringe is designed for manual use.

Source page: https://510kreport.com/device/K991225
Methodology: https://510kreport.com/methodology