# K061275: Medline Syringes, Multiple

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Jul 19, 2006 after 72 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Apr 22, 2024 · Class II · Z-1937-2024: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a 
- Apr 22, 2024 · Class II · Z-1938-2024: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a 

## Indications for use
Medline disposable sterile syringes are intended for use to inject fluids into, or withdraw fluids from, the body. Medline disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K061275
Methodology: https://510kreport.com/methodology