# K243149: Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

- Pathway: 510(k) (Traditional)
- Applicant: Congruence Medical Solutions, LLC
- Decided: Dec 20, 2024 after 81 days
- Product code: QLY (Ophthalmic Syringe)
- 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
Longest line of descent: 6 generations back to K931367 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200242: StaClear Syringe, Tribofilm Research, Inc. (2020) Summary page 5.

## Indications for use
The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.

Source page: https://510kreport.com/device/K243149
Methodology: https://510kreport.com/methodology